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FDA 510(k)

MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP

K-Number: K912266 · 1991-08-20

ApplicantOrothmet, Inc.
Decision Date1991-08-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP is the device name listed in this FDA 510(k) record. The listed applicant is Orothmet, Inc.. It received FDA 510(k) clearance on 1991-08-20 under 510(k) number K912266. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP?

MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP is a medical device that received FDA 510(k) clearance on 1991-08-20. The listed applicant is Orothmet, Inc.. The 510(k) number is K912266.

When did MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP receive FDA 510(k) clearance?

MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP received FDA 510(k) clearance on 1991-08-20, under 510(k) number K912266.

Who is the listed applicant for MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP?

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

What is the FDA product code for MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP?

The FDA product code for MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP is JWH.

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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.

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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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