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FDA 510(k)

ORTHOFIX AXIALEXTERNAL FIXATION SYS.

K-Number: K802814 · 1980-12-10

ApplicantCintor Orthopaedic Div.
Decision Date1980-12-10
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX AXIALEXTERNAL FIXATION SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Cintor Orthopaedic Div.. It received FDA 510(k) clearance on 1980-12-10 under 510(k) number K802814. 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 ORTHOFIX AXIALEXTERNAL FIXATION SYS.?

ORTHOFIX AXIALEXTERNAL FIXATION SYS. is a medical device that received FDA 510(k) clearance on 1980-12-10. The listed applicant is Cintor Orthopaedic Div.. The 510(k) number is K802814.

When did ORTHOFIX AXIALEXTERNAL FIXATION SYS. receive FDA 510(k) clearance?

ORTHOFIX AXIALEXTERNAL FIXATION SYS. received FDA 510(k) clearance on 1980-12-10, under 510(k) number K802814.

Who is the listed applicant for ORTHOFIX AXIALEXTERNAL FIXATION SYS.?

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

What is the FDA product code for ORTHOFIX AXIALEXTERNAL FIXATION SYS.?

The FDA product code for ORTHOFIX AXIALEXTERNAL FIXATION SYS. is JEC.

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Other records listing Cintor Orthopaedic Div. 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.

K811451RADIAL HEAD PROSTHESISK810540KNEE PROSTHESISK810353HARRIS CEMENT RESTRICTORK803106AGINSKY NAILK803074FERNORAL HIP PROSTHESISK802627ORTRON 90* HIP PROSTHESIS

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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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