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FDA 510(k)

OTI ORTHOPEDIC WIRE SYSTEM

K-Number: K925447 · 1993-06-29

ApplicantOsteo Technology, Inc.
Decision Date1993-06-29
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OTI ORTHOPEDIC WIRE 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 1993-06-29 under 510(k) number K925447. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTI ORTHOPEDIC WIRE SYSTEM?

OTI ORTHOPEDIC WIRE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is Osteo Technology, Inc.. The 510(k) number is K925447.

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

OTI ORTHOPEDIC WIRE SYSTEM received FDA 510(k) clearance on 1993-06-29, under 510(k) number K925447.

Who is the listed applicant for OTI ORTHOPEDIC WIRE 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 WIRE SYSTEM?

The FDA product code for OTI ORTHOPEDIC WIRE SYSTEM is JDQ.

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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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