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FDA 510(k)

WHITESIDE ORTHOLOC II METAL BACKED PATELLA

K-Number: K864627 · 1987-02-04

ApplicantDow Corning Wright
Decision Date1987-02-04
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

WHITESIDE ORTHOLOC II METAL BACKED PATELLA is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Wright. It received FDA 510(k) clearance on 1987-02-04 under 510(k) number K864627. 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 WHITESIDE ORTHOLOC II METAL BACKED PATELLA?

WHITESIDE ORTHOLOC II METAL BACKED PATELLA is a medical device that received FDA 510(k) clearance on 1987-02-04. The listed applicant is Dow Corning Wright. The 510(k) number is K864627.

When did WHITESIDE ORTHOLOC II METAL BACKED PATELLA receive FDA 510(k) clearance?

WHITESIDE ORTHOLOC II METAL BACKED PATELLA received FDA 510(k) clearance on 1987-02-04, under 510(k) number K864627.

Who is the listed applicant for WHITESIDE ORTHOLOC II METAL BACKED PATELLA?

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

What is the FDA product code for WHITESIDE ORTHOLOC II METAL BACKED PATELLA?

The FDA product code for WHITESIDE ORTHOLOC II METAL BACKED PATELLA is JWH.

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Other records listing Dow Corning Wright 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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