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FDA 510(k)

SPINAL WRENCH

K-Number: K813067 · 1981-11-24

ApplicantTwin City Surgical, Inc.
Decision Date1981-11-24
Product CodeHXC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL WRENCH is the device name listed in this FDA 510(k) record. The listed applicant is Twin City Surgical, Inc.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813067. The device is classified under product code HXC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL WRENCH?

SPINAL WRENCH is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Twin City Surgical, Inc.. The 510(k) number is K813067.

When did SPINAL WRENCH receive FDA 510(k) clearance?

SPINAL WRENCH received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813067.

Who is the listed applicant for SPINAL WRENCH?

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

What is the FDA product code for SPINAL WRENCH?

The FDA product code for SPINAL WRENCH is HXC.

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.

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Other records listing Twin City Surgical, 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.

K870767THE (CROM) TESTERK861632SIMS CHAIRK830585ANVIL RETRACTORK820659A CALIPERK820660A HOOK DRIVER

Related Devices (Code: HXC)

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.

K180092IntellitorqGauthier Biomedical, Inc.K874358COMBINATION WRENCHESMed-Tool, Inc.K874359ADJUSTABLE WRENCHESMed-Tool, Inc.K870053TORQUEDRIVER WRENCHJerome MedicalK791073WRENCHTruth, Inc.

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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