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FDA 510(k)

IN:C2 SPINAL FIXATION SYSTEM

K-Number: K122630 · 2012-12-05

ApplicantSpine Smith Partners L.P.
Decision Date2012-12-05
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IN:C2 SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spine Smith Partners L.P.. It received FDA 510(k) clearance on 2012-12-05 under 510(k) number K122630. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN:C2 SPINAL FIXATION SYSTEM?

IN:C2 SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-05. The listed applicant is Spine Smith Partners L.P.. The 510(k) number is K122630.

When did IN:C2 SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

IN:C2 SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2012-12-05, under 510(k) number K122630.

Who is the listed applicant for IN:C2 SPINAL FIXATION SYSTEM?

The FDA 510(k) record lists Spine Smith Partners L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IN:C2 SPINAL FIXATION SYSTEM?

The FDA product code for IN:C2 SPINAL FIXATION SYSTEM is OVE.

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Other records listing Spine Smith Partners L.P. 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.

K122168VISUALIF CHALLENGING ACCESS PLATEK102090SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEMK101085SPINESMITH CYNCH SPINAL SYSTEMK090376SPINESMITH CYNCH SPINAL SYSTEMK082821SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEMK081132SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

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Related Devices (Code: OVE)

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.

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, 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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