Cleared Special

K133321 - ALAMO C

K133321 is an FDA 510(k) clearance for ALAMO C, manufactured by Alliance Partners, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 72-day FDA review.

K133321 · Alliance Partners, LLC · Orthopedic device
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Jan 2014
Decision
72d
Days
Class 2
Risk

K133321 is an FDA 510(k) clearance for the ALAMO C. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Alliance Partners, LLC (Avon Lake, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alliance Partners, LLC devices

FDA 510(k) Submission Details - K133321

510(k) Number K133321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2013
Decision Date January 09, 2014
Days to Decision 72 days
Submission Type Special
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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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 312
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K133321.
VELOFIXTM INTERBODY FUSION SYSTEM
K132926 · U&I Corp. · Mar 2014
C-BOX PEEK CERVICAL IBF
K132991 · Innovasis, Inc. · Feb 2014
C-PLUS
K133623 · Pioneer Surgical Technology, Inc. · Feb 2014
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
K130317 · Genesys Spine · Dec 2013
PERIMETER C SPINAL SYSTEM
K132584 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
INTEGRITY SPINE CORE SYSTEM
K132718 · Integrity Spine · Nov 2013