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FDA 510(k)

AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT

K-Number: K902259 · 1990-06-18

ApplicantOrthomet, Inc.
Decision Date1990-06-18
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent for Some Indications

Device Summary

AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1990-06-18 under 510(k) number K902259. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT?

AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT is a medical device that received FDA 510(k) clearance on 1990-06-18. The listed applicant is Orthomet, Inc.. The 510(k) number is K902259.

When did AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT receive FDA 510(k) clearance?

AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT received FDA 510(k) clearance on 1990-06-18, under 510(k) number K902259.

Who is the listed applicant for AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT?

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 AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT?

The FDA product code for AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT is JWX.

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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.

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Related Devices (Code: JWX)

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.

K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, Inc.

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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