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FDA 510(k)

Physica KR Liner and SMR Reverse Humeral Liner

K-Number: K190911 · 2019-11-26

ApplicantLimacorporate
Decision Date2019-11-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Physica KR Liner and SMR Reverse Humeral Liner is the device name listed in this FDA 510(k) record. The listed applicant is Limacorporate. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K190911. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Physica KR Liner and SMR Reverse Humeral Liner?

Physica KR Liner and SMR Reverse Humeral Liner is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Limacorporate. The 510(k) number is K190911.

When did Physica KR Liner and SMR Reverse Humeral Liner receive FDA 510(k) clearance?

Physica KR Liner and SMR Reverse Humeral Liner received FDA 510(k) clearance on 2019-11-26, under 510(k) number K190911.

Who is the listed applicant for Physica KR Liner and SMR Reverse Humeral Liner?

The FDA 510(k) record lists Limacorporate as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Physica KR Liner and SMR Reverse Humeral Liner?

The FDA product code for Physica KR Liner and SMR Reverse Humeral Liner is JWH.

Other records listing Limacorporate 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.

K243809Biolox® Delta Revision headsK213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidK211938Physica LMC Knee System

Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

Official Source

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

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