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FDA 510(k)

SPINAL USA INTERBODY FUSION DEVICE

K-Number: K080314 · 2008-05-13

ApplicantSpinal USA
Decision Date2008-05-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPINAL USA 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 2008-05-13 under 510(k) number K080314. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAL USA INTERBODY FUSION DEVICE?

SPINAL USA INTERBODY FUSION DEVICE is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Spinal USA. The 510(k) number is K080314.

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

SPINAL USA INTERBODY FUSION DEVICE received FDA 510(k) clearance on 2008-05-13, under 510(k) number K080314.

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

The FDA product code for SPINAL USA INTERBODY FUSION DEVICE is MAX.

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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: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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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