Cleared Traditional

K083118 - SPINAL USA ANTERIOR CERVICAL INTERBODY ...

K083118 is an FDA 510(k) clearance for SPINAL USA ANTERIOR CERVICAL INTERBODY ..., manufactured by Spinal USA. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K083118 · Spinal USA · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2009
Decision
217d
Days
Class 2
Risk

K083118 is an FDA 510(k) clearance for the SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spinal USA (Pear, US). The FDA issued a Cleared decision on May 27, 2009 after a review of 217 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Spinal USA devices

FDA 510(k) Submission Details - K083118

510(k) Number K083118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2008
Decision Date May 27, 2009
Days to Decision 217 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 122d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 242
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K083118.
TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S
K091873 · Spineart · Sep 2009
NUBIC AND RABEA DEVICES
K082848 · Signus Medizintechnik GmbH · Jul 2009
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
K091088 · Ldr Spine USA · Jul 2009
CALIX SPINAL IMPLANT SYSTEM
K083637 · X-Spine Systems, Inc. · Apr 2009
CAMBRIA
K082309 · Seaspine, Inc. · Apr 2009
NUVASIVE COROENT SYSTEM
K081611 · Nuvasive, Inc. · Oct 2008