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FDA 510(k)

ACE/KYLE CAPTURED HIP SCREW

K-Number: K813554 · 1982-01-12

ApplicantAce Orthopedic Manufacturing Co.
Decision Date1982-01-12
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE/KYLE CAPTURED HIP SCREW 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 1982-01-12 under 510(k) number K813554. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE/KYLE CAPTURED HIP SCREW?

ACE/KYLE CAPTURED HIP SCREW is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Ace Orthopedic Manufacturing Co.. The 510(k) number is K813554.

When did ACE/KYLE CAPTURED HIP SCREW receive FDA 510(k) clearance?

ACE/KYLE CAPTURED HIP SCREW received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813554.

Who is the listed applicant for ACE/KYLE CAPTURED HIP SCREW?

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/KYLE CAPTURED HIP SCREW?

The FDA product code for ACE/KYLE CAPTURED HIP SCREW is KTT.

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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 PLATEK810193TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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