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FDA 510(k)

GAMMA SYSTEM

K-Number: K955473 · 1996-02-16

ApplicantZimmer, Inc.
Decision Date1996-02-16
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAMMA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1996-02-16 under 510(k) number K955473. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA SYSTEM?

GAMMA SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-16. The listed applicant is Zimmer, Inc.. The 510(k) number is K955473.

When did GAMMA SYSTEM receive FDA 510(k) clearance?

GAMMA SYSTEM received FDA 510(k) clearance on 1996-02-16, under 510(k) number K955473.

Who is the listed applicant for GAMMA SYSTEM?

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

What is the FDA product code for GAMMA SYSTEM?

The FDA product code for GAMMA SYSTEM is JDI.

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Other records listing Zimmer, Inc. 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.

K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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