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FDA 510(k)

AMATOMICAL SHOULDER WITH REMOVABLE HEAD

K-Number: K030259 · 2003-04-24

ApplicantCenterplus Orthopedics, Inc.
Decision Date2003-04-24
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMATOMICAL SHOULDER WITH REMOVABLE HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Centerplus Orthopedics, Inc.. It received FDA 510(k) clearance on 2003-04-24 under 510(k) number K030259. 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 AMATOMICAL SHOULDER WITH REMOVABLE HEAD?

AMATOMICAL SHOULDER WITH REMOVABLE HEAD is a medical device that received FDA 510(k) clearance on 2003-04-24. The listed applicant is Centerplus Orthopedics, Inc.. The 510(k) number is K030259.

When did AMATOMICAL SHOULDER WITH REMOVABLE HEAD receive FDA 510(k) clearance?

AMATOMICAL SHOULDER WITH REMOVABLE HEAD received FDA 510(k) clearance on 2003-04-24, under 510(k) number K030259.

Who is the listed applicant for AMATOMICAL SHOULDER WITH REMOVABLE HEAD?

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

What is the FDA product code for AMATOMICAL SHOULDER WITH REMOVABLE HEAD?

The FDA product code for AMATOMICAL SHOULDER WITH REMOVABLE HEAD 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.

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Other records listing Centerplus 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.

K023528NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE

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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