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FDA 510(k)

SMR TT Metal Back Glenoid, Bone Graft instruments

K-Number: K161120 · 2017-02-21

ApplicantLima Corporate S.P.A.
Decision Date2017-02-21
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMR TT Metal Back Glenoid, Bone Graft instruments 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 2017-02-21 under 510(k) number K161120. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMR TT Metal Back Glenoid, Bone Graft instruments?

SMR TT Metal Back Glenoid, Bone Graft instruments is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K161120.

When did SMR TT Metal Back Glenoid, Bone Graft instruments receive FDA 510(k) clearance?

SMR TT Metal Back Glenoid, Bone Graft instruments received FDA 510(k) clearance on 2017-02-21, under 510(k) number K161120.

Who is the listed applicant for SMR TT Metal Back Glenoid, Bone Graft instruments?

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 TT Metal Back Glenoid, Bone Graft instruments?

The FDA product code for SMR TT Metal Back Glenoid, Bone Graft instruments is PHX.

Related Clinical Trials

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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: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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