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FDA 510(k)

ANATOMICAL TYPE KNEE SYSTEM

K-Number: K922859 · 1993-09-23

ApplicantOsteo Technology, Inc.
Decision Date1993-09-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANATOMICAL TYPE KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteo Technology, Inc.. It received FDA 510(k) clearance on 1993-09-23 under 510(k) number K922859. 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 ANATOMICAL TYPE KNEE SYSTEM?

ANATOMICAL TYPE KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-09-23. The listed applicant is Osteo Technology, Inc.. The 510(k) number is K922859.

When did ANATOMICAL TYPE KNEE SYSTEM receive FDA 510(k) clearance?

ANATOMICAL TYPE KNEE SYSTEM received FDA 510(k) clearance on 1993-09-23, under 510(k) number K922859.

Who is the listed applicant for ANATOMICAL TYPE KNEE SYSTEM?

The FDA 510(k) record lists Osteo Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANATOMICAL TYPE KNEE SYSTEM?

The FDA product code for ANATOMICAL TYPE KNEE SYSTEM is JWH.

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Other records listing Osteo Technology, Inc. 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.

K926156REPLICA(TM) TOTAL HIP SYSTEMK922869TOTAL CONDYLAT TYPE KNEE SYSTEMK925447OTI ORTHOPEDIC WIRE SYSTEMK926213MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEMK922861BIOMETRIC SCREW FIXATION CUPK922870THREE SPIKE CUP

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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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