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FDA 510(k)

SMR SHOULDER SYSTEM- REVISION STEMS

K-Number: K111212 · 2011-07-28

ApplicantLima Corporate S.P.A.
Decision Date2011-07-28
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR SHOULDER SYSTEM- REVISION STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2011-07-28 under 510(k) number K111212. 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 SMR SHOULDER SYSTEM- REVISION STEMS?

SMR SHOULDER SYSTEM- REVISION STEMS is a medical device that received FDA 510(k) clearance on 2011-07-28. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K111212.

When did SMR SHOULDER SYSTEM- REVISION STEMS receive FDA 510(k) clearance?

SMR SHOULDER SYSTEM- REVISION STEMS received FDA 510(k) clearance on 2011-07-28, under 510(k) number K111212.

Who is the listed applicant for SMR SHOULDER SYSTEM- REVISION STEMS?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMR SHOULDER SYSTEM- REVISION STEMS?

The FDA product code for SMR SHOULDER SYSTEM- REVISION STEMS is KWS.

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Other records listing Lima Corporate S.P.A. 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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