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FDA 510(k)

TENET TIBIAL FRACTURE SUPPORT

K-Number: K964102 · 1996-12-05

ApplicantTenet Medical Engineering
Decision Date1996-12-05
Product CodeGBB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TENET TIBIAL FRACTURE SUPPORT is the device name listed in this FDA 510(k) record. The listed applicant is Tenet Medical Engineering. It received FDA 510(k) clearance on 1996-12-05 under 510(k) number K964102. The device is classified under product code GBB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENET TIBIAL FRACTURE SUPPORT?

TENET TIBIAL FRACTURE SUPPORT is a medical device that received FDA 510(k) clearance on 1996-12-05. The listed applicant is Tenet Medical Engineering. The 510(k) number is K964102.

When did TENET TIBIAL FRACTURE SUPPORT receive FDA 510(k) clearance?

TENET TIBIAL FRACTURE SUPPORT received FDA 510(k) clearance on 1996-12-05, under 510(k) number K964102.

Who is the listed applicant for TENET TIBIAL FRACTURE SUPPORT?

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

What is the FDA product code for TENET TIBIAL FRACTURE SUPPORT?

The FDA product code for TENET TIBIAL FRACTURE SUPPORT is GBB.

Related Clinical Trials

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.

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Other records listing Tenet Medical Engineering 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.

K963505TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEMK963506TENET RADIOLUCENT HAND TABLE

Related Devices (Code: GBB)

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.

K893598HYDRAULIC FOOT OPERATED STOOLArthro-Medic, Inc.K831385LITHOTOMY CHAIR #415Midmark Corp.K831325NUTROMATMedlog GmbH Marketing ServicesK822264NAGASHIMA SN OPERATOR'S CHAIRKelleher Corp.K822251EXAMINATION & TREATMENT CHAIRSKelleher Corp.K822013NAGASHIMA SN AUTOMATIC TREATMENT CHAIRKelleher Corp.

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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