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FDA 510(k)

SMR Shoulder System

K-Number: K223876 · 2023-02-03

ApplicantLima Corporate S.P.A.
Decision Date2023-02-03
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR Shoulder System 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 2023-02-03 under 510(k) number K223876. 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 SMR Shoulder System?

SMR Shoulder System is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K223876.

When did SMR Shoulder System receive FDA 510(k) clearance?

SMR Shoulder System received FDA 510(k) clearance on 2023-02-03, under 510(k) number K223876.

Who is the listed applicant for SMR Shoulder System?

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?

The FDA product code for SMR Shoulder System is MBF.

Other records listing Lima Corporate S.P.A. 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.

K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemK251718ArTT Augments and Buttresses and Bone ScrewsK243826SMR Reverse HP Shoulder SystemK250980Physica System (Physica CR Porous Femoral components)K243615Physica Porous Femoral ComponentsK234011AMF TT Cones

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Related Devices (Code: MBF)

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.

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima 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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