Cleared Special

K062810 - SOLITAIRE ANTERIOR SPINAL SYSTEM

K062810 is an FDA 510(k) clearance for SOLITAIRE ANTERIOR SPINAL SYSTEM, manufactured by Ebi, L.P.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 28-day FDA review.

K062810 · Ebi, L.P. · Orthopedic device
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Oct 2006
Decision
28d
Days
Class 2
Risk

K062810 is an FDA 510(k) clearance for the SOLITAIRE ANTERIOR SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on October 17, 2006 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Ebi, L.P. devices

FDA 510(k) Submission Details - K062810

510(k) Number K062810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2006
Decision Date October 17, 2006
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 267
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K062810.
SSP VERTEBRAL BODY REPLACEMENT
K061578 · Specialty Spine Products, LLC · Dec 2006
BOX PEEK VBR SYSTEM
K062151 · Innovasis, Inc. · Dec 2006
MOBIS SPINAL IMPLANT
K061082 · Signus Medizintechnik GmbH · Dec 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K062133 · Medtronic Spinal and Biologics Div · Sep 2006
VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
K061155 · Zimmer Trabecular · Sep 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006