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FDA 510(k)

HALO SUPPORT JACKET & ASSOC. HARDWARE

K-Number: K792586 · 1979-12-31

ApplicantDepuy, Inc.
Decision Date1979-12-31
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HALO SUPPORT JACKET & ASSOC. HARDWARE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1979-12-31 under 510(k) number K792586. 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 HALO SUPPORT JACKET & ASSOC. HARDWARE?

HALO SUPPORT JACKET & ASSOC. HARDWARE is a medical device that received FDA 510(k) clearance on 1979-12-31. The listed applicant is Depuy, Inc.. The 510(k) number is K792586.

When did HALO SUPPORT JACKET & ASSOC. HARDWARE receive FDA 510(k) clearance?

HALO SUPPORT JACKET & ASSOC. HARDWARE received FDA 510(k) clearance on 1979-12-31, under 510(k) number K792586.

Who is the listed applicant for HALO SUPPORT JACKET & ASSOC. HARDWARE?

The FDA 510(k) record lists Depuy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALO SUPPORT JACKET & ASSOC. HARDWARE?

The FDA product code for HALO SUPPORT JACKET & ASSOC. HARDWARE is HAX.

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Other records listing Depuy, Inc. as applicant

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K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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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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