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FDA 510(k)

TORQUEDRIVER WRENCH

K-Number: K870053 · 1987-03-11

ApplicantJerome Medical
Decision Date1987-03-11
Product CodeHXC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TORQUEDRIVER WRENCH is the device name listed in this FDA 510(k) record. The listed applicant is Jerome Medical. It received FDA 510(k) clearance on 1987-03-11 under 510(k) number K870053. 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 TORQUEDRIVER WRENCH?

TORQUEDRIVER WRENCH is a medical device that received FDA 510(k) clearance on 1987-03-11. The listed applicant is Jerome Medical. The 510(k) number is K870053.

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

TORQUEDRIVER WRENCH received FDA 510(k) clearance on 1987-03-11, under 510(k) number K870053.

Who is the listed applicant for TORQUEDRIVER WRENCH?

The FDA 510(k) record lists Jerome Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TORQUEDRIVER WRENCH?

The FDA product code for TORQUEDRIVER WRENCH is HXC.

Related Clinical Trials

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Other records listing Jerome Medical 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.

K051918RESOLVE OPEN BACK HALO RINGSK930021J TONGSK930153SYSTEM III HALO RINGK882877JMS CERVICAL TRACTION DEVICE/HALO DEVICEK864969JMS HALO APPLICATION TRAYK844490TRACTION ACCESSORIES

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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.K813067SPINAL WRENCHTwin City Surgical, Inc.K791073WRENCHTruth, Inc.

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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