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FDA 510(k)

NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW

K-Number: K931651 · 1994-07-18

ApplicantIntermedics Orthopedics
Decision Date1994-07-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K931651. 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 NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW?

NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Intermedics Orthopedics. The 510(k) number is K931651.

When did NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW receive FDA 510(k) clearance?

NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW received FDA 510(k) clearance on 1994-07-18, under 510(k) number K931651.

Who is the listed applicant for NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW?

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

What is the FDA product code for NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW?

The FDA product code for NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW is JWH.

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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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