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FDA 510(k)

SYSTEM III HALO RING

K-Number: K930153 · 1993-08-06

ApplicantJerome Medical
Decision Date1993-08-06
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYSTEM III HALO RING is the device name listed in this FDA 510(k) record. The listed applicant is Jerome Medical. It received FDA 510(k) clearance on 1993-08-06 under 510(k) number K930153. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM III HALO RING?

SYSTEM III HALO RING is a medical device that received FDA 510(k) clearance on 1993-08-06. The listed applicant is Jerome Medical. The 510(k) number is K930153.

When did SYSTEM III HALO RING receive FDA 510(k) clearance?

SYSTEM III HALO RING received FDA 510(k) clearance on 1993-08-06, under 510(k) number K930153.

Who is the listed applicant for SYSTEM III HALO RING?

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

What is the FDA product code for SYSTEM III HALO RING?

The FDA product code for SYSTEM III HALO RING is JEC.

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Other records listing Jerome Medical 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.

K051918RESOLVE OPEN BACK HALO RINGSK930021J TONGSK882877JMS CERVICAL TRACTION DEVICE/HALO DEVICEK870053TORQUEDRIVER WRENCHK864969JMS HALO APPLICATION TRAYK844490TRACTION ACCESSORIES

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Related Devices (Code: JEC)

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.

K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, 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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