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FDA 510(k)

INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE

K-Number: K830121 · 1983-04-26

ApplicantZimmer, Inc.
Decision Date1983-04-26
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1983-04-26 under 510(k) number K830121. 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 INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE?

INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE is a medical device that received FDA 510(k) clearance on 1983-04-26. The listed applicant is Zimmer, Inc.. The 510(k) number is K830121.

When did INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE receive FDA 510(k) clearance?

INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE received FDA 510(k) clearance on 1983-04-26, under 510(k) number K830121.

Who is the listed applicant for INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE?

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 INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE?

The FDA product code for INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE is JWH.

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Other records listing Zimmer, Inc. as applicant

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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: 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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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