Cleared Traditional

K962645 - ISOLA TWISTER CONNECTOR

K962645 is an FDA 510(k) clearance for ISOLA TWISTER CONNECTOR, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K962645 · Acromed Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
106d
Days
Class 2
Risk

K962645 is an FDA 510(k) clearance for the ISOLA TWISTER CONNECTOR. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on October 22, 1996 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Acromed Corp. devices

FDA 510(k) Submission Details - K962645

510(k) Number K962645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1996
Decision Date October 22, 1996
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K962645.
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
K963357 · Synthes (Usa) · Jan 1997
ACROMED CABLE/WIRE PEDICLE SCREW
K964007 · Acromed Corp. · Dec 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · Synthes (Usa) · Dec 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572 · Wrightmedicaltechnologyinc · Sep 1996
DDS SPINAL SYSTEM
K960107 · Encore Orthopedics, Inc. · May 1996
WEBB-MORLEY SPINE SYSTEM
K960451 · Buckman Co., Inc. · Apr 1996