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FDA 510(k)

SPINE WORKS COLLAR

K-Number: K003662 · 2001-07-09

ApplicantSpine Works
Decision Date2001-07-09
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPINE WORKS COLLAR is the device name listed in this FDA 510(k) record. The listed applicant is Spine Works. It received FDA 510(k) clearance on 2001-07-09 under 510(k) number K003662. 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 SPINE WORKS COLLAR?

SPINE WORKS COLLAR is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is Spine Works. The 510(k) number is K003662.

When did SPINE WORKS COLLAR receive FDA 510(k) clearance?

SPINE WORKS COLLAR received FDA 510(k) clearance on 2001-07-09, under 510(k) number K003662.

Who is the listed applicant for SPINE WORKS COLLAR?

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

What is the FDA product code for SPINE WORKS COLLAR?

The FDA product code for SPINE WORKS COLLAR is HAX.

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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.K980689FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFriddle'S Orthopedic Appliances, Inc.K930021J TONGSJerome Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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