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FDA 510(k)

TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG

K-Number: K810193 · 1981-03-20

ApplicantAce Orthopedic Manufacturing Co.
Decision Date1981-03-20
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG 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 1981-03-20 under 510(k) number K810193. The device is classified under product code HAX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG?

TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is Ace Orthopedic Manufacturing Co.. The 510(k) number is K810193.

When did TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG receive FDA 510(k) clearance?

TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810193.

Who is the listed applicant for TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG?

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 TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG?

The FDA product code for TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG is HAX.

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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

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Related Devices (Code: HAX)

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.

K090733PMT HALO SYSTEMPmt Corp.K071173RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DOssur Americans (Formerly the Jerome Group)K051918RESOLVE OPEN BACK HALO RINGSJerome MedicalK023959JEROME GLASS RINGThe Jerome Group, Inc.K003662SPINE WORKS COLLARSpine WorksK980689FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFriddle'S Orthopedic Appliances, 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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