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FDA 510(k)

ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED

K-Number: K933304 · 1993-08-30

ApplicantDepuy, Inc.
Decision Date1993-08-30
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1993-08-30 under 510(k) number K933304. 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 ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED?

ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED is a medical device that received FDA 510(k) clearance on 1993-08-30. The listed applicant is Depuy, Inc.. The 510(k) number is K933304.

When did ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED receive FDA 510(k) clearance?

ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED received FDA 510(k) clearance on 1993-08-30, under 510(k) number K933304.

Who is the listed applicant for ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED?

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

What is the FDA product code for ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED?

The FDA product code for ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED is JWH.

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Other records listing Depuy, Inc. as applicant

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K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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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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