Cleared Traditional

K082309 - CAMBRIA

K082309 is an FDA 510(k) clearance for CAMBRIA, manufactured by Seaspine, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K082309 · Seaspine, Inc. · Orthopedic device
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Apr 2009
Decision
239d
Days
Class 2
Risk

K082309 is an FDA 510(k) clearance for the CAMBRIA. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on April 9, 2009 after a review of 239 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 Seaspine, Inc. devices

FDA 510(k) Submission Details - K082309

510(k) Number K082309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2008
Decision Date April 09, 2009
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
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 350
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K082309.
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
K091088 · Ldr Spine USA · Jul 2009
SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
K083118 · Spinal USA · May 2009
CALIX SPINAL IMPLANT SYSTEM
K083637 · X-Spine Systems, Inc. · Apr 2009
FUSION ADVANTAGE CERVICAL CAGE, FUSION ADVANTAGE LUMBAR CAGE
K083425 · Adaptive Specialty, LLC · Mar 2009
AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
K083311 · Aesculap Implant Systems, Inc. · Mar 2009
PHENIX CERVICAL INTERBODY DEVICE
K083167 · Spinal Devices, LLC · Jan 2009