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FDA 510(k)

OEC/REZAIAN SPINAL FIXATOR

K-Number: K841189 · 1984-05-16

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1984-05-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OEC/REZAIAN SPINAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1984-05-16 under 510(k) number K841189. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OEC/REZAIAN SPINAL FIXATOR?

OEC/REZAIAN SPINAL FIXATOR is a medical device that received FDA 510(k) clearance on 1984-05-16. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K841189.

When did OEC/REZAIAN SPINAL FIXATOR receive FDA 510(k) clearance?

OEC/REZAIAN SPINAL FIXATOR received FDA 510(k) clearance on 1984-05-16, under 510(k) number K841189.

Who is the listed applicant for OEC/REZAIAN SPINAL FIXATOR?

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

What is the FDA product code for OEC/REZAIAN SPINAL FIXATOR?

The FDA product code for OEC/REZAIAN SPINAL FIXATOR is KWQ.

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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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