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FDA 510(k)

NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM

K-Number: K955778 · 1996-03-08

ApplicantIntermedics Orthopedics
Decision Date1996-03-08
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

NATURAL-KNEE II UNICOMPARTMENTALKNEE 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 1996-03-08 under 510(k) number K955778. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM?

NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-08. The listed applicant is Intermedics Orthopedics. The 510(k) number is K955778.

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

NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM received FDA 510(k) clearance on 1996-03-08, under 510(k) number K955778.

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

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

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Related Devices (Code: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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