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FDA 510(k)

OTI ORTHOPEDIC FASTENER SYSTEM

K-Number: K925301 · 1993-03-16

ApplicantOsteo Technology, Inc.
Decision Date1993-03-16
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI ORTHOPEDIC FASTENER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteo Technology, Inc.. It received FDA 510(k) clearance on 1993-03-16 under 510(k) number K925301. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTI ORTHOPEDIC FASTENER SYSTEM?

OTI ORTHOPEDIC FASTENER SYSTEM is a medical device that received FDA 510(k) clearance on 1993-03-16. The listed applicant is Osteo Technology, Inc.. The 510(k) number is K925301.

When did OTI ORTHOPEDIC FASTENER SYSTEM receive FDA 510(k) clearance?

OTI ORTHOPEDIC FASTENER SYSTEM received FDA 510(k) clearance on 1993-03-16, under 510(k) number K925301.

Who is the listed applicant for OTI ORTHOPEDIC FASTENER SYSTEM?

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

What is the FDA product code for OTI ORTHOPEDIC FASTENER SYSTEM?

The FDA product code for OTI ORTHOPEDIC FASTENER SYSTEM is HTY.

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Other records listing Osteo Technology, Inc. as applicant

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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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