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FDA 510(k)

M.C.R. KNEE PROSTHESIS (SERIES 3000)

K-Number: K860654 · 1986-03-14

ApplicantOsteonics Corp.
Decision Date1986-03-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

M.C.R. KNEE PROSTHESIS (SERIES 3000) is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1986-03-14 under 510(k) number K860654. 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 M.C.R. KNEE PROSTHESIS (SERIES 3000)?

M.C.R. KNEE PROSTHESIS (SERIES 3000) is a medical device that received FDA 510(k) clearance on 1986-03-14. The listed applicant is Osteonics Corp.. The 510(k) number is K860654.

When did M.C.R. KNEE PROSTHESIS (SERIES 3000) receive FDA 510(k) clearance?

M.C.R. KNEE PROSTHESIS (SERIES 3000) received FDA 510(k) clearance on 1986-03-14, under 510(k) number K860654.

Who is the listed applicant for M.C.R. KNEE PROSTHESIS (SERIES 3000)?

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

What is the FDA product code for M.C.R. KNEE PROSTHESIS (SERIES 3000)?

The FDA product code for M.C.R. KNEE PROSTHESIS (SERIES 3000) is JWH.

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Other records listing Osteonics Corp. 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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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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