Cleared Traditional

K962757 - J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP

K962757 is an FDA 510(k) clearance for J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS..., manufactured by J.B.S., S.A.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K962757 · J.B.S., S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
71d
Days
Class 2
Risk

K962757 is an FDA 510(k) clearance for the J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LIN.... Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by J.B.S., S.A. (Pleasenton, US). The FDA issued a Cleared decision on September 25, 1996 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all J.B.S., S.A. devices

FDA 510(k) Submission Details - K962757

510(k) Number K962757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1996
Decision Date September 25, 1996
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 253
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K962757.
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · Synthes (Usa) · Dec 1996
ISOLA TWISTER CONNECTOR
K962645 · Acromed Corp. · Oct 1996
ULTIUM SPINAL PLATING SYSTEM
K962784 · Smith & Nephew, Inc., Orthopaedic Div. · Oct 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