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FDA 510(k)

SYNFIX-LR SPACER

K-Number: K072253 · 2007-10-12

ApplicantSynthes Spine Co.Lp
Decision Date2007-10-12
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNFIX-LR SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine Co.Lp. It received FDA 510(k) clearance on 2007-10-12 under 510(k) number K072253. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNFIX-LR SPACER?

SYNFIX-LR SPACER is a medical device that received FDA 510(k) clearance on 2007-10-12. The listed applicant is Synthes Spine Co.Lp. The 510(k) number is K072253.

When did SYNFIX-LR SPACER receive FDA 510(k) clearance?

SYNFIX-LR SPACER received FDA 510(k) clearance on 2007-10-12, under 510(k) number K072253.

Who is the listed applicant for SYNFIX-LR SPACER?

The FDA 510(k) record lists Synthes Spine Co.Lp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNFIX-LR SPACER?

The FDA product code for SYNFIX-LR SPACER is OVD.

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Other records listing Synthes Spine Co.Lp 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.

K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)K112459SYNTHES ZERO-PK112068SYNTHES ZERO-P VARIABLE ANGLE (VA)K103320SYNTHES XRLK081568ANTEGRA-TK080020ARCOFIX

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Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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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