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FDA 510(k)

PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM

K-Number: K911197 · 1991-05-23

ApplicantOrthomet, Inc.
Decision Date1991-05-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1991-05-23 under 510(k) number K911197. 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 PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM?

PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-05-23. The listed applicant is Orthomet, Inc.. The 510(k) number is K911197.

When did PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM received FDA 510(k) clearance on 1991-05-23, under 510(k) number K911197.

Who is the listed applicant for PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM?

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

What is the FDA product code for PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM?

The FDA product code for PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM is JWH.

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Other records listing Orthomet, 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.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK945783ORTHOMET TITANIUM HYBRID FEMORAL STEMK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK944752ORTHOMET RESURFACING FEMORAL COMPONENTK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER

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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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