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FDA 510(k)

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid

K-Number: K213785 · 2022-05-13

ApplicantLimacorporate
Decision Date2022-05-13
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Limacorporate. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K213785. 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 TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid?

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Limacorporate. The 510(k) number is K213785.

When did SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid receive FDA 510(k) clearance?

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid received FDA 510(k) clearance on 2022-05-13, under 510(k) number K213785.

Who is the listed applicant for SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid?

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

What is the FDA product code for SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid?

The FDA product code for SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid is KWS.

Other records listing Limacorporate 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.

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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

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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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