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FDA 510(k)

SYNTHES ACIS/VERTEBRAL SPACER CR

K-Number: K120275 · 2012-05-25

ApplicantSynthes (Usa), LLC
Decision Date2012-05-25
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES ACIS/VERTEBRAL SPACER CR is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa), LLC. It received FDA 510(k) clearance on 2012-05-25 under 510(k) number K120275. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES ACIS/VERTEBRAL SPACER CR?

SYNTHES ACIS/VERTEBRAL SPACER CR is a medical device that received FDA 510(k) clearance on 2012-05-25. The listed applicant is Synthes (Usa), LLC. The 510(k) number is K120275.

When did SYNTHES ACIS/VERTEBRAL SPACER CR receive FDA 510(k) clearance?

SYNTHES ACIS/VERTEBRAL SPACER CR received FDA 510(k) clearance on 2012-05-25, under 510(k) number K120275.

Who is the listed applicant for SYNTHES ACIS/VERTEBRAL SPACER CR?

The FDA 510(k) record lists Synthes (Usa), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES ACIS/VERTEBRAL SPACER CR?

The FDA product code for SYNTHES ACIS/VERTEBRAL SPACER CR is ODP.

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Other records listing Synthes (Usa), LLC 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.

K180821TruMatch Graft Cage - Long BoneK161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemK130146SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEMK112030SYNTHES RADIAL HEAD PROSTHESIS SYSTEMK1015362.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM

Related Devices (Code: ODP)

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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Official Source

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