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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 a medical device manufactured by Limacorporate. It received FDA 510(k) clearance on 2022-05-13 under approval 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. It is manufactured by Limacorporate. The 510(k) number is K213785.

When was SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid approved by the FDA?

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

What company makes SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid?

SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid is manufactured by Limacorporate.

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 Devices by Limacorporate

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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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