Cleared Traditional

K130573 - TYBER MEDICAL INTERBODY SYSTEM

Also marketed or referenced as:
ACIF, ALIF, PLIF, TLIF, DLIF

K130573 is an FDA 510(k) clearance for TYBER MEDICAL INTERBODY SYSTEM, manufactured by Tyber Medical, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K130573 · Tyber Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
210d
Days
Class 2
Risk

K130573 is an FDA 510(k) clearance for the TYBER MEDICAL INTERBODY SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Morristown, US). The FDA issued a Cleared decision on September 30, 2013 after a review of 210 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 Tyber Medical, LLC devices

FDA 510(k) Submission Details - K130573

510(k) Number K130573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date September 30, 2013
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 K130573.
PERIMETER C SPINAL SYSTEM
K132584 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
INTEGRITY SPINE CORE SYSTEM
K132718 · Integrity Spine · Nov 2013
IDYS(TM) C
K130853 · Clariance · Nov 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
RELIANCE CERVICAL IBF SYSTEM
K131429 · Reliance Medical Systems, LLC · Sep 2013
C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K130948 · Southern Spine, LLC · Aug 2013