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FDA 510(k)

POLI-AXIAL KNEE CAGE

K-Number: K812064 · 1981-08-13

ApplicantGeneration II Orthotics, Inc.
Decision Date1981-08-13
Product CodeITM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POLI-AXIAL KNEE CAGE is the device name listed in this FDA 510(k) record. The listed applicant is Generation II Orthotics, Inc.. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K812064. The device is classified under product code ITM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLI-AXIAL KNEE CAGE?

POLI-AXIAL KNEE CAGE is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Generation II Orthotics, Inc.. The 510(k) number is K812064.

When did POLI-AXIAL KNEE CAGE receive FDA 510(k) clearance?

POLI-AXIAL KNEE CAGE received FDA 510(k) clearance on 1981-08-13, under 510(k) number K812064.

Who is the listed applicant for POLI-AXIAL KNEE CAGE?

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

What is the FDA product code for POLI-AXIAL KNEE CAGE?

The FDA product code for POLI-AXIAL KNEE CAGE is ITM.

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Related Devices (Code: ITM)

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.

K832742EXTENSION CONTROL KNEE ORTHOSISOrthomedicsK770899FRACTURE CAST BRACE, POLYChase Mfg. Co.K770900CAST BRWM, FRACTUREChase Mfg. Co.K760573IMPROVED KNEE DRESSINGRichard'S Medical Equip., 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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