Cleared Special

K000236 - SYNERGY VLS CAP NUT MODELS 2206

K000236 is an FDA 510(k) clearance for SYNERGY VLS CAP NUT MODELS 2206, manufactured by Interpore Cross Intl.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 20-day FDA review.

K000236 · Interpore Cross Intl. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
20d
Days
Class 2
Risk

K000236 is an FDA 510(k) clearance for the SYNERGY VLS CAP NUT MODELS 2206, 6102. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on February 16, 2000 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Interpore Cross Intl. devices

FDA 510(k) Submission Details - K000236

510(k) Number K000236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2000
Decision Date February 16, 2000
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 162
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K000236.
MODIFICATION TO EBI SPINELINK SYSTEM
K001037 · Ebi, L.P. · Apr 2000
MODIFICATION TO SYNTHES USS
K000450 · Synthes Spine · Mar 2000
ISOBAR SPINAL SYSTEM
K000425 · Encore Orthopedics, Inc. · Mar 2000
OPUS SPINAL SYSTEM
K993402 · Howmedica Osteonics Corp. · Dec 1999
EBI SPINELINK SYSTEM
K992920 · Ebi, L.P. · Nov 1999
ISOBAR SPINAL SYSTEM
K992738 · Encore Orthopedics, Inc. · Nov 1999