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FDA 510(k)

NATURAL-KNEE II SYSTEM

K-Number: K936159 · 1995-05-22

ApplicantIntermedics Orthopedics
Decision Date1995-05-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

NATURAL-KNEE II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K936159. 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 II SYSTEM?

NATURAL-KNEE II SYSTEM is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Intermedics Orthopedics. The 510(k) number is K936159.

When did NATURAL-KNEE II SYSTEM receive FDA 510(k) clearance?

NATURAL-KNEE II SYSTEM received FDA 510(k) clearance on 1995-05-22, under 510(k) number K936159.

Who is the listed applicant for NATURAL-KNEE II SYSTEM?

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 II SYSTEM?

The FDA product code for NATURAL-KNEE II SYSTEM is JWH.

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Other records listing Intermedics Orthopedics as applicant

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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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