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FDA 510(k)

PSK POSTERIOR STABILIZED TOATAL KNEE

K-Number: K915798 · 1993-03-04

ApplicantImplantology Corp.
Decision Date1993-03-04
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PSK POSTERIOR STABILIZED TOATAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Implantology Corp.. It received FDA 510(k) clearance on 1993-03-04 under 510(k) number K915798. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSK POSTERIOR STABILIZED TOATAL KNEE?

PSK POSTERIOR STABILIZED TOATAL KNEE is a medical device that received FDA 510(k) clearance on 1993-03-04. The listed applicant is Implantology Corp.. The 510(k) number is K915798.

When did PSK POSTERIOR STABILIZED TOATAL KNEE receive FDA 510(k) clearance?

PSK POSTERIOR STABILIZED TOATAL KNEE received FDA 510(k) clearance on 1993-03-04, under 510(k) number K915798.

Who is the listed applicant for PSK POSTERIOR STABILIZED TOATAL KNEE?

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

What is the FDA product code for PSK POSTERIOR STABILIZED TOATAL KNEE?

The FDA product code for PSK POSTERIOR STABILIZED TOATAL KNEE is JWH.

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Other records listing Implantology 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.

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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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