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FDA 510(k)

INSALL-BURSTEIN II

K-Number: K935080 · 1995-05-22

ApplicantHospital For Special Surgery
Decision Date1995-05-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

INSALL-BURSTEIN II is the device name listed in this FDA 510(k) record. The listed applicant is Hospital For Special Surgery. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K935080. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the INSALL-BURSTEIN II?

INSALL-BURSTEIN II is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Hospital For Special Surgery. The 510(k) number is K935080.

When did INSALL-BURSTEIN II receive FDA 510(k) clearance?

INSALL-BURSTEIN II received FDA 510(k) clearance on 1995-05-22, under 510(k) number K935080.

Who is the listed applicant for INSALL-BURSTEIN II?

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

What is the FDA product code for INSALL-BURSTEIN II?

The FDA product code for INSALL-BURSTEIN II is JWH.

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Other records listing Hospital For Special Surgery 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.

K942032PLAMP, PLAMP PLATE, PLAMP WITH HOOKK934857HSS FEMORAL COMPONENTS

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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