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FDA 510(k)

THREADED PIN, SELF DRILLING

K-Number: K781251 · 1978-08-31

ApplicantAce Orthopedic Manufacturing Co.
Decision Date1978-08-31
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THREADED PIN, SELF DRILLING 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 1978-08-31 under 510(k) number K781251. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THREADED PIN, SELF DRILLING?

THREADED PIN, SELF DRILLING is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Ace Orthopedic Manufacturing Co.. The 510(k) number is K781251.

When did THREADED PIN, SELF DRILLING receive FDA 510(k) clearance?

THREADED PIN, SELF DRILLING received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781251.

Who is the listed applicant for THREADED PIN, SELF DRILLING?

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 THREADED PIN, SELF DRILLING?

The FDA product code for THREADED PIN, SELF DRILLING is JDW.

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

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Related Devices (Code: JDW)

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker 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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