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FDA 510(k)

OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT

K-Number: K962082 · 1996-08-13

ApplicantOsteonics Corp.
Decision Date1996-08-13
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1996-08-13 under 510(k) number K962082. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT?

OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT is a medical device that received FDA 510(k) clearance on 1996-08-13. The listed applicant is Osteonics Corp.. The 510(k) number is K962082.

When did OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT receive FDA 510(k) clearance?

OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT received FDA 510(k) clearance on 1996-08-13, under 510(k) number K962082.

Who is the listed applicant for OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT?

The FDA 510(k) record lists Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT?

The FDA product code for OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT is KWS.

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Other records listing Osteonics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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Related Devices (Code: KWS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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