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FDA 510(k)

CIMPLICITY SPINAL SYSTEM

K-Number: K073320 · 2008-02-07

ApplicantSpine Smith Partners L.P.
Decision Date2008-02-07
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CIMPLICITY SPINAL 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 2008-02-07 under 510(k) number K073320. 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 CIMPLICITY SPINAL SYSTEM?

CIMPLICITY SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-07. The listed applicant is Spine Smith Partners L.P.. The 510(k) number is K073320.

When did CIMPLICITY SPINAL SYSTEM receive FDA 510(k) clearance?

CIMPLICITY SPINAL SYSTEM received FDA 510(k) clearance on 2008-02-07, under 510(k) number K073320.

Who is the listed applicant for CIMPLICITY SPINAL 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 CIMPLICITY SPINAL SYSTEM?

The FDA product code for CIMPLICITY SPINAL SYSTEM is ODP.

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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.

K122630IN:C2 SPINAL FIXATION SYSTEMK122168VISUALIF CHALLENGING ACCESS PLATEK102090SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEMK101085SPINESMITH CYNCH SPINAL SYSTEMK090376SPINESMITH CYNCH SPINAL SYSTEMK082821SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM

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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.

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

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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