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FDA 510(k)

ACE UNILATERAL FIXATOR II

K-Number: K936045 · 1994-02-22

ApplicantAce Orthopedic Manufacturing Co.
Decision Date1994-02-22
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE UNILATERAL FIXATOR II is the device name listed in this FDA 510(k) record. The listed applicant is Ace Orthopedic Manufacturing Co.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K936045. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE UNILATERAL FIXATOR II?

ACE UNILATERAL FIXATOR II is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Ace Orthopedic Manufacturing Co.. The 510(k) number is K936045.

When did ACE UNILATERAL FIXATOR II receive FDA 510(k) clearance?

ACE UNILATERAL FIXATOR II received FDA 510(k) clearance on 1994-02-22, under 510(k) number K936045.

Who is the listed applicant for ACE UNILATERAL FIXATOR II?

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

What is the FDA product code for ACE UNILATERAL FIXATOR II?

The FDA product code for ACE UNILATERAL FIXATOR II is JEC.

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Other records listing Ace Orthopedic Manufacturing Co. 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.

K934643ACE HUMERAL NAILK934962AIM SUPRACONDYLAR NAILK926047ACE 8.0MM CANNULATED CANCELLOUS BONE SCREWK920738ACE 100 DEGREES TUBULAR PLATEK813554ACE/KYLE CAPTURED HIP SCREWK810193TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG

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Related Devices (Code: JEC)

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.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, 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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