Cleared Special

K122742 - NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM

K122742 is an FDA 510(k) clearance for NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Special 510(k) pathway after a 91-day FDA review.

K122742 · Nuvasive, Inc. · Orthopedic device
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Dec 2012
Decision
91d
Days
Class 2
Risk

K122742 is an FDA 510(k) clearance for the NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM. Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on December 7, 2012 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nuvasive, Inc. devices

FDA 510(k) Submission Details - K122742

510(k) Number K122742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2012
Decision Date December 07, 2012
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

OLO Device Classification - Class 2, Special Controls

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
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 - OLO Orthopedic Stereotaxic Instrument

All 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K122742.
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