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FDA 510(k)

OSTEO EX-FI-RE

K-Number: K920149 · 1992-04-09

ApplicantOsteo AG
Decision Date1992-04-09
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO EX-FI-RE is the device name listed in this FDA 510(k) record. The listed applicant is Osteo AG. It received FDA 510(k) clearance on 1992-04-09 under 510(k) number K920149. 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 OSTEO EX-FI-RE?

OSTEO EX-FI-RE is a medical device that received FDA 510(k) clearance on 1992-04-09. The listed applicant is Osteo AG. The 510(k) number is K920149.

When did OSTEO EX-FI-RE receive FDA 510(k) clearance?

OSTEO EX-FI-RE received FDA 510(k) clearance on 1992-04-09, under 510(k) number K920149.

Who is the listed applicant for OSTEO EX-FI-RE?

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

What is the FDA product code for OSTEO EX-FI-RE?

The FDA product code for OSTEO EX-FI-RE is JEC.

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Other records listing Osteo AG 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.

K933340OSTEO INTERLOCKING-COMPRESSION NAILK922194OSTEO STEINMANN PINK922195OSTEO FEMORAL NAILK922196OSTEO TIBIA NAILK922193OSTEO KIRSCHNER WIREK920037OSTEO COMPRESSION HIP SCREW

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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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