Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SMR Stemless Anatomic

K-Number: K221758 · 2023-03-17

ApplicantLima Corporate S.P.A.
Decision Date2023-03-17
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR Stemless Anatomic 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 2023-03-17 under 510(k) number K221758. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMR Stemless Anatomic?

SMR Stemless Anatomic is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K221758.

When did SMR Stemless Anatomic receive FDA 510(k) clearance?

SMR Stemless Anatomic received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221758.

Who is the listed applicant for SMR Stemless Anatomic?

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 Stemless Anatomic?

The FDA product code for SMR Stemless Anatomic is PKC.

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

View all 41 devices →

Related Devices (Code: PKC)

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.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K220418Tornier Perform Humeral System – StemlessTornier, 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.

↑