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FDA 510(k)

TEW CRANIAL/SPINAL RETRACTOR MODEL A1090

K-Number: K960807 · 1996-05-17

Decision Date1996-05-17
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Instrument Co., Inc.. It received FDA 510(k) clearance on 1996-05-17 under 510(k) number K960807. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEW CRANIAL/SPINAL RETRACTOR MODEL A1090?

TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 is a medical device that received FDA 510(k) clearance on 1996-05-17. The listed applicant is Ohio Medical Instrument Co., Inc.. The 510(k) number is K960807.

When did TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 receive FDA 510(k) clearance?

TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 received FDA 510(k) clearance on 1996-05-17, under 510(k) number K960807.

Who is the listed applicant for TEW CRANIAL/SPINAL RETRACTOR MODEL A1090?

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

What is the FDA product code for TEW CRANIAL/SPINAL RETRACTOR MODEL A1090?

The FDA product code for TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 is GZT.

Related Clinical Trials

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.

Other records listing Ohio Medical Instrument Co., Inc. as applicant

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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Related Devices (Code: GZT)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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