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FDA 510(k)

PRIMA Humeral System; PRIMA TT Glenoid

K-Number: K233712 · 2024-01-11

ApplicantLima Corporate S.P.A.
Decision Date2024-01-11
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRIMA Humeral System; PRIMA TT Glenoid is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2024-01-11 under approval number K233712. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMA Humeral System; PRIMA TT Glenoid?

PRIMA Humeral System; PRIMA TT Glenoid is a medical device that received FDA 510(k) clearance on 2024-01-11. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K233712.

When was PRIMA Humeral System; PRIMA TT Glenoid approved by the FDA?

PRIMA Humeral System; PRIMA TT Glenoid received FDA 510(k) clearance on 2024-01-11, under approval number K233712.

What company makes PRIMA Humeral System; PRIMA TT Glenoid?

PRIMA Humeral System; PRIMA TT Glenoid is manufactured by Lima Corporate S.P.A..

What is the FDA product code for PRIMA Humeral System; PRIMA TT Glenoid?

The FDA product code for PRIMA Humeral System; PRIMA TT Glenoid is MBF.

Related Clinical Trials

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Other Devices by Lima Corporate S.P.A.

K160011H-Max S stem K161476SMR Shoulder System K153722SMR 3-Pegs Glenoids K170473C2 femoral stem K163397SMR Hybrid Glenoid System K161120SMR TT Metal Back Glenoid, Bone Graft instruments

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Related Devices (Code: MBF)

K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie K173824Humeral Short Stem SystemShoulder Innovations, Inc. K191963SMR Finned Short StemsLima Corporate S.P.A. K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.

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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