FDA 510(k)

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012

K-Number: K100741 · 2010-08-02

Decision Date2010-08-02

Product CodePHX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2010-08-02 under 510(k) number K100741. 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 REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012?

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 is a medical device that received FDA 510(k) clearance on 2010-08-02. The listed applicant is Encore Medical L.P.. The 510(k) number is K100741.

When did REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 receive FDA 510(k) clearance?

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 received FDA 510(k) clearance on 2010-08-02, under 510(k) number K100741.

Who is the listed applicant for REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012?

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

What is the FDA product code for REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012?

The FDA product code for REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 is PHX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Encore Medical L.P. as applicant

K252567AltiVate Reverse® ADLC Glenosphere K252974EMPOWR Knee K251833EMPOWR Acetabular® Liner Extension K252141AltiVate Reverse® Glenoid K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

View all 75 devices →

Related Devices (Code: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment 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, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive 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.