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FDA 510(k)

ORION BLADE PLATE FOR TIBIAL OSTEOTOMY

K-Number: K901272 · 1990-04-23

ApplicantMed-Tek Corp.
Decision Date1990-04-23
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORION BLADE PLATE FOR TIBIAL OSTEOTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tek Corp.. It received FDA 510(k) clearance on 1990-04-23 under 510(k) number K901272. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION BLADE PLATE FOR TIBIAL OSTEOTOMY?

ORION BLADE PLATE FOR TIBIAL OSTEOTOMY is a medical device that received FDA 510(k) clearance on 1990-04-23. The listed applicant is Med-Tek Corp.. The 510(k) number is K901272.

When did ORION BLADE PLATE FOR TIBIAL OSTEOTOMY receive FDA 510(k) clearance?

ORION BLADE PLATE FOR TIBIAL OSTEOTOMY received FDA 510(k) clearance on 1990-04-23, under 510(k) number K901272.

Who is the listed applicant for ORION BLADE PLATE FOR TIBIAL OSTEOTOMY?

The FDA 510(k) record lists Med-Tek Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION BLADE PLATE FOR TIBIAL OSTEOTOMY?

The FDA product code for ORION BLADE PLATE FOR TIBIAL OSTEOTOMY is KTT.

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Other records listing Med-Tek Corp. as applicant

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Related Devices (Code: KTT)

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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