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FDA 510(k)

NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION

K-Number: K934166 · 1994-09-07

ApplicantCorin Orthopedic Products
Decision Date1994-09-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Corin Orthopedic Products. It received FDA 510(k) clearance on 1994-09-07 under 510(k) number K934166. 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 NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION?

NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-09-07. The listed applicant is Corin Orthopedic Products. The 510(k) number is K934166.

When did NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION receive FDA 510(k) clearance?

NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION received FDA 510(k) clearance on 1994-09-07, under 510(k) number K934166.

Who is the listed applicant for NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION?

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

What is the FDA product code for NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION?

The FDA product code for NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION is JWH.

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.

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Other records listing Corin Orthopedic Products 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.

K931753CORIN THOMPSON PROSTHESIS, MODIFICATIONK931752CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATIONK925866CENATOR TOTAL HIP SYSTEMK925897CORIN BIPOLAR PROSTHESIS

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

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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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