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FDA 510(k)

SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE

K-Number: K083118 · 2009-05-27

ApplicantSpinal USA
Decision Date2009-05-27
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Spinal USA. It received FDA 510(k) clearance on 2009-05-27 under 510(k) number K083118. 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 SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE?

SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Spinal USA. The 510(k) number is K083118.

When did SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE receive FDA 510(k) clearance?

SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE received FDA 510(k) clearance on 2009-05-27, under 510(k) number K083118.

Who is the listed applicant for SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE?

The FDA 510(k) record lists Spinal USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE?

The FDA product code for SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE is ODP.

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Other records listing Spinal USA 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.

K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICEK130863FACET SCREW SYSTEMK131343REFORM PEDICLE SCREW SYSTEMK130279REFORM PEDICLE SCREW SYSTEMK130445VAULT ALIF SYSTEMK122931S-LOK PSS 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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