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FDA 510(k)

REVERSE SHOULDER PROSTHESIS

K-Number: K092873 · 2009-10-27

ApplicantDjo Surgical
Decision Date2009-10-27
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVERSE SHOULDER PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Djo Surgical. It received FDA 510(k) clearance on 2009-10-27 under 510(k) number K092873. 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?

REVERSE SHOULDER PROSTHESIS is a medical device that received FDA 510(k) clearance on 2009-10-27. The listed applicant is Djo Surgical. The 510(k) number is K092873.

When did REVERSE SHOULDER PROSTHESIS receive FDA 510(k) clearance?

REVERSE SHOULDER PROSTHESIS received FDA 510(k) clearance on 2009-10-27, under 510(k) number K092873.

Who is the listed applicant for REVERSE SHOULDER PROSTHESIS?

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

What is the FDA product code for REVERSE SHOULDER PROSTHESIS?

The FDA product code for REVERSE SHOULDER PROSTHESIS is PHX.

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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

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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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