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 3-Pegs Glenoids

K-Number: K153722 · 2016-04-06

ApplicantLima Corporate S.P.A.
Decision Date2016-04-06
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR 3-Pegs Glenoids 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 2016-04-06 under 510(k) number K153722. 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 3-Pegs Glenoids?

SMR 3-Pegs Glenoids is a medical device that received FDA 510(k) clearance on 2016-04-06. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K153722.

When did SMR 3-Pegs Glenoids receive FDA 510(k) clearance?

SMR 3-Pegs Glenoids received FDA 510(k) clearance on 2016-04-06, under 510(k) number K153722.

Who is the listed applicant for SMR 3-Pegs Glenoids?

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 3-Pegs Glenoids?

The FDA product code for SMR 3-Pegs Glenoids is KWS.

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: 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑