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FDA 510(k)

INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM

K-Number: K892228 · 1989-10-06

ApplicantIntermedics Orthopedics
Decision Date1989-10-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K892228. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM?

INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Intermedics Orthopedics. The 510(k) number is K892228.

When did INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM receive FDA 510(k) clearance?

INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM received FDA 510(k) clearance on 1989-10-06, under 510(k) number K892228.

Who is the listed applicant for INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM?

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

What is the FDA product code for INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM?

The FDA product code for INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM is HRS.

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Related Devices (Code: HRS)

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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