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FDA 510(k)

SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS

K-Number: K971715 · 1997-08-07

ApplicantSulzer Orthopedics, Inc.
Decision Date1997-08-07
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 1997-08-07 under 510(k) number K971715. 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 SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS?

SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS is a medical device that received FDA 510(k) clearance on 1997-08-07. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K971715.

When did SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS receive FDA 510(k) clearance?

SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS received FDA 510(k) clearance on 1997-08-07, under 510(k) number K971715.

Who is the listed applicant for SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS?

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

What is the FDA product code for SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS?

The FDA product code for SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS is KWS.

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Other records listing Sulzer Orthopedics, Inc. 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.

K022985ASCENDENT ACETABULAR SYSTEMK021578NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATEK020713MS-30 LATERAL FEMORAL STEMK013935ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTSK013031MOST OPTIONS SYSTEMK012739CONVERGE ACETABULAR SYSTEM

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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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