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FDA 510(k)

AIM SUPRACONDYLAR NAIL

K-Number: K934962 · 1994-03-22

ApplicantAce Orthopedic Manufacturing Co.
Decision Date1994-03-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AIM SUPRACONDYLAR NAIL 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 1994-03-22 under 510(k) number K934962. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIM SUPRACONDYLAR NAIL?

AIM SUPRACONDYLAR NAIL is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Ace Orthopedic Manufacturing Co.. The 510(k) number is K934962.

When did AIM SUPRACONDYLAR NAIL receive FDA 510(k) clearance?

AIM SUPRACONDYLAR NAIL received FDA 510(k) clearance on 1994-03-22, under 510(k) number K934962.

Who is the listed applicant for AIM SUPRACONDYLAR NAIL?

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 AIM SUPRACONDYLAR NAIL?

The FDA product code for AIM SUPRACONDYLAR NAIL is HSB.

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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 NAILK936045ACE UNILATERAL FIXATOR IIK926047ACE 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: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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