High Class Dental,
Dynatronics Corporation,
Isokinetics Inc,
more...
Stellar Orthopedics, Inc.,
Aqua Creek Products,
Ferno Performance Pools,
more...
Novacare Rehabilitation
Alimed, Inc.,
Isokinetics Inc,
I-Rep Inc,
more...
Ultimate Water Massage
Slawner Ltd., J.
Patterson Medical Products, Inc.,
Bruno Independent Living Aids Inc.
AMS Vans, Inc,
Harmar Mobility,
American Ramp Systems,
more...
Orthomerica Products, Inc.,
Restorative Care of America, Inc.,
DM Systems, Inc,
more...
Lundy Medical Products, LLC,
Mizuho OSI,
Brown Medical Industries,
more...
Cardiac Science, Inc.,
Flexiciser International Corp. Inc.,
All Pro Exercise Products, Inc.,
more...
Mizuho OSI,
Zimmer, Inc.,
ShopAircast.com,
more...
Innovative Medical Products, Inc,
Arthur Finnieston Clinic,
Capital Prosthetic Manufacturing, Inc.,
more...
Cloward Instruments Corporation,
Alimed, Inc.,
Rehamed Intl. LLC.,
more...
DJ Orthopedics Inc.,
Zimmer, Inc.,
Biomet, Inc,
more...
DJ Orthopedics Inc.,
Zimmer, Inc.,
Biomet, Inc,
more...
DJ Orthopedics Inc.,
Medical Gear For Life,
Zimmer, Inc.,
more...
(FDA Code:
ILI /
890.364)
Identification. An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.
Wyatt Health,
Hub4Health.com,
Raytek Corp.,
more...
(FDA Code:
IOY /
890.3475)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.
Pro Orthopedic Devices,
Nihon Kohden America, Inc.,
VQ OrthoCare,
more...
Westmed Inc.,
Vital Signs, Inc.,
Radiometer Ltd.,
more...
Kinetikos Medical, Inc.,
Depuy Orthopaedics, Inc.,
Acumed LLC
Depuy Orthopaedics, Inc.,
Biomet, Inc,
Orthofix Inc.
Marconi Medizintechnik Deutschland GmbH
(FDA Code:
LYH /
890.1615)
Medmetric Corp,
Sport Tech, Inc.,
Genourob
Mizuho OSI,
ProEndoscopy,
Stryker,
more...
(FDA Code:
HRX /
888.11)
Arthroscope is a thin flexible fiberoptic scope that is introduced into a joint space through a small incision in order to carry out diagnostic and treatment procedures within the joint. It is about the diameter of a drinking straw. It is fitted with a miniature camera, a light source and precision tools at the end of flexible tubes. It can be used not only for diagnostic procedures but a wide range of surgical repairs, such as debridement, or cleaning, of a joint to remove bits of torn cartilage, ligament reconstruction, and synovectomy (removal of the joint lining).
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
Classification. (1) Class II (performance standards).
Depuy Orthopaedics, Inc.,
Whittemore Enterprises, Inc.,
Nuvasive Inc.,
more...
(FDA Code:
NBH /
888.11)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
Classification. (1) Class II (performance standards).
W. l. Gore & Associates, Inc.,
Nuvasive Inc.,
Medtronic Xomed Surgical Products, Inc,
more...
Ankle joint distractor is designed for spreading an ankle joint in preparation for arthroscopic surgery. It consists of a pair of external fixation pins for transfixing bones adjacent the ankle joint so as to pass parallel to one another and directly through the bones from the medial side to the lateral side, and a pair of jackscrews for attachment to the parallelly transfixed pins. The jackscrews are adapted to force the pins apart or together so as to distract or to compress the ankle joint while the pins are maintained in a generally parallel spaced apart relationship.
Depuy Orthopaedics, Inc.,
MSI Precision Specialty Instruments,
Otto Bock Healthcare, Lp,
more...
Allen Medical Systems,
Surgistar Inc.,
Peridot Corporation,
more...
Arthroscopic meniscal repair system allows control the amount of compression across the tear ensuring a secure repair. It consists of three components including a soft tissue anchor, a connecting suture, and a top hat, which compresses the meniscus tear against the anchor. It comes in both non-absorbable and absorbable options.
Depuy Orthopaedics, Inc.,
Autosuture,
Innomed, Inc.,
more...
Depuy Orthopaedics, Inc.,
MSI Precision Specialty Instruments
Contec Medical System
Smith & Nephew Inc.,
Mahe International Inc.,
Herger AG,
more...
Arthroscopy drill guide system is designed for the precise guidewire placement required for repair of osteochondral lesions of the talus, arthroscopic fracture fixation with cannulated screws and arthroscopic arthrodesis. Its compact, lightweight design is ideal for small joint spaces. It is easy-to-handle and provides the stability required for precise guidewire insertion. Its articulating arm design ensures constant alignment of distal ends for precise K-wire placement.
Depuy Orthopaedics, Inc.,
KLS Martin, L.P.,
Zimmer, Inc.,
more...
Surgical Tools, Inc.,
Richard Wolf Medical Instruments Corp.,
Torwin Surgical Industries,
more...
Arthroscopy instruments are designed to safely and easily establish the posterolateral and anterolateral portals usually ranging from o 5 mm - o 10 mm. Using a series of portal dilators and two-piece cannulas, the arthroscopist can quickly switch between working and viewing portals while maintaining access to the portals throughout the process. These instruments use standard length arthroscopies and include arthroscope cannula caps that mate securely to various styles of arthroscopies.
Depuy Orthopaedics, Inc.,
Arthrex, Inc.,
Biomet, Inc,
more...
Mizuho OSI,
Maramed Orthopedic Systems,
Allen Medical Systems,
more...
MSI Precision Specialty Instruments,
Sklar Instruments,
Symmetry Tnco,
more...
Karl Storz Endoscopy,
Depuy Orthopaedics, Inc.,
Stryker,
more...
Arthroscopy shoulder instrument set is a comprehensive set of manual instruments that can be used for arthroscopic or mini-open shoulder repairs. It is designed to allow flexibility in suture passing and suture retrieving methods that are critical to success in these procedures.
Depuy Orthopaedics, Inc.,
DePuy Orthopaedics, Inc,
MSI Precision Specialty Instruments,
more...
Ackermann Instrumente Gmbh
Hi-Tec Medical Gmbh
Sklar Instruments
Sklar Instruments,
Medical Products Resource,
HMNGB Crocomed Technik Inc.
Sklar Instruments
Sklar Instruments,
Gyrx, LLC,
HMNGB Crocomed Technik Inc.
Sklar Instruments,
Symmetry Medical USA, Inc.
Sklar Instruments,
Sterilmed, Inc.
Sklar Instruments,
Symmetry Medical USA, Inc.
Sklar Instruments