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FDA 510(k)

ACE FISCHER EXTERNAL FIXATION DEVICE

K-Number: K801594 · 1980-09-09

ApplicantAce Orthopedic Manufacturing Co.
Decision Date1980-09-09
Product CodeHXK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE FISCHER EXTERNAL FIXATION DEVICE 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 1980-09-09 under 510(k) number K801594. The device is classified under product code HXK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE FISCHER EXTERNAL FIXATION DEVICE?

ACE FISCHER EXTERNAL FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Ace Orthopedic Manufacturing Co.. The 510(k) number is K801594.

When did ACE FISCHER EXTERNAL FIXATION DEVICE receive FDA 510(k) clearance?

ACE FISCHER EXTERNAL FIXATION DEVICE received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801594.

Who is the listed applicant for ACE FISCHER EXTERNAL FIXATION DEVICE?

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 FISCHER EXTERNAL FIXATION DEVICE?

The FDA product code for ACE FISCHER EXTERNAL FIXATION DEVICE is HXK.

Related Clinical Trials

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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.

K934962AIM SUPRACONDYLAR NAILK934643ACE HUMERAL NAILK936045ACE UNILATERAL FIXATOR IIK926047ACE 8.0MM CANNULATED CANCELLOUS BONE SCREWK920738ACE 100 DEGREES TUBULAR PLATEK813554ACE/KYLE CAPTURED HIP SCREW

View all 14 devices →

Related Devices (Code: HXK)

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.

K890167HOLDER, NEEDLEDhason Brothers, Inc.K872989MICRINS NEEDLE HOLDERMicrins Surgical, Inc.K860018FISCHER WIRE/PIN CLAMPBuckman Co., Inc.K772388CONVERSE-GILLIES NEEDLE HOLDEREdward Weck, 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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