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FDA 510(k)

OSTEONICS SR GLENOID COMPONENTS

K-Number: K903886 · 1990-11-20

ApplicantOsteonics Reconstructive Products Div.
Decision Date1990-11-20
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OSTEONICS SR GLENOID COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Reconstructive Products Div.. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K903886. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OSTEONICS SR GLENOID COMPONENTS?

OSTEONICS SR GLENOID COMPONENTS is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Osteonics Reconstructive Products Div.. The 510(k) number is K903886.

When did OSTEONICS SR GLENOID COMPONENTS receive FDA 510(k) clearance?

OSTEONICS SR GLENOID COMPONENTS received FDA 510(k) clearance on 1990-11-20, under 510(k) number K903886.

Who is the listed applicant for OSTEONICS SR GLENOID COMPONENTS?

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

What is the FDA product code for OSTEONICS SR GLENOID COMPONENTS?

The FDA product code for OSTEONICS SR GLENOID COMPONENTS is KWS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Osteonics Reconstructive Products Div. 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.

K895378PROXIMAL CEMENT SPACER

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

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

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