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FDA 510(k)

ACE CERVICAL TRACTION HALOZS, TONGS & PINS

K-Number: K954069 · 1995-10-12

ApplicantAce Medical Co.
Decision Date1995-10-12
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACE CERVICAL TRACTION HALOZS, TONGS & PINS is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Co.. It received FDA 510(k) clearance on 1995-10-12 under 510(k) number K954069. 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 ACE CERVICAL TRACTION HALOZS, TONGS & PINS?

ACE CERVICAL TRACTION HALOZS, TONGS & PINS is a medical device that received FDA 510(k) clearance on 1995-10-12. The listed applicant is Ace Medical Co.. The 510(k) number is K954069.

When did ACE CERVICAL TRACTION HALOZS, TONGS & PINS receive FDA 510(k) clearance?

ACE CERVICAL TRACTION HALOZS, TONGS & PINS received FDA 510(k) clearance on 1995-10-12, under 510(k) number K954069.

Who is the listed applicant for ACE CERVICAL TRACTION HALOZS, TONGS & PINS?

The FDA 510(k) record lists Ace Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE CERVICAL TRACTION HALOZS, TONGS & PINS?

The FDA product code for ACE CERVICAL TRACTION HALOZS, TONGS & PINS is HAX.

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Other records listing Ace Medical 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.

K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILK955472ACE HUMERUS & RADIUS PLATESK955388ACE-DUPONT COMPOSITE RINGSK9544856.5MM SOLID CANCELLOUS BONE SCREWK950618ACE SUPRACONDYLAR PLATEK933968ACE PELVIC STABILIZER

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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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