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FDA 510(k)

SPINE-FIX BIOMIMETIC BONE CEMENT

K-Number: K043593 · 2006-03-17

ApplicantTeknimed, S.A.
Decision Date2006-03-17
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINE-FIX BIOMIMETIC BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Teknimed, S.A.. It received FDA 510(k) clearance on 2006-03-17 under 510(k) number K043593. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINE-FIX BIOMIMETIC BONE CEMENT?

SPINE-FIX BIOMIMETIC BONE CEMENT is a medical device that received FDA 510(k) clearance on 2006-03-17. The listed applicant is Teknimed, S.A.. The 510(k) number is K043593.

When did SPINE-FIX BIOMIMETIC BONE CEMENT receive FDA 510(k) clearance?

SPINE-FIX BIOMIMETIC BONE CEMENT received FDA 510(k) clearance on 2006-03-17, under 510(k) number K043593.

Who is the listed applicant for SPINE-FIX BIOMIMETIC BONE CEMENT?

The FDA 510(k) record lists Teknimed, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINE-FIX BIOMIMETIC BONE CEMENT?

The FDA product code for SPINE-FIX BIOMIMETIC BONE CEMENT is NDN.

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Other records listing Teknimed, S.A. 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.

K103433F20K090435VERTECEMK083005NANGELK080873OPACITY + BONE CEMENTK062102ODONCERK042911CEMENTEK LV

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Related Devices (Code: NDN)

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.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

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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