Cleared Traditional

K132991 - C-BOX PEEK CERVICAL IBF

K132991 is an FDA 510(k) clearance for C-BOX PEEK CERVICAL IBF, manufactured by Innovasis, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K132991 · Innovasis, Inc. · Orthopedic device
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Feb 2014
Decision
141d
Days
Class 2
Risk

K132991 is an FDA 510(k) clearance for the C-BOX PEEK CERVICAL IBF. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 12, 2014 after a review of 141 days - within the typical 510(k) review window.

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 Innovasis, Inc. devices

FDA 510(k) Submission Details - K132991

510(k) Number K132991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2013
Decision Date February 12, 2014
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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 336
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K132991.
INNESIS PEEK CERVICAL CAGE
K132483 · Bk Meditech, Co., Ltd. · Apr 2014
CAMBER SPINE COVERIS CERVICAL CAGE
K133529 · Camber Spine · Mar 2014
VELOFIXTM INTERBODY FUSION SYSTEM
K132926 · U&I Corp. · Mar 2014
C-PLUS
K133623 · Pioneer Surgical Technology, Inc. · Feb 2014
ALAMO C
K133321 · Alliance Partners, LLC · Jan 2014
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
K130317 · Genesys Spine · Dec 2013