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FDA 510(k)

INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP

K-Number: K881836 · 1988-08-29

ApplicantIntermedics Orthopedics
Decision Date1988-08-29
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1988-08-29 under 510(k) number K881836. 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 INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP?

INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP is a medical device that received FDA 510(k) clearance on 1988-08-29. The listed applicant is Intermedics Orthopedics. The 510(k) number is K881836.

When did INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP receive FDA 510(k) clearance?

INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP received FDA 510(k) clearance on 1988-08-29, under 510(k) number K881836.

Who is the listed applicant for INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP?

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

What is the FDA product code for INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP?

The FDA product code for INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP is KWS.

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Other records listing Intermedics Orthopedics as applicant

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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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