Cleared Traditional

K953881 - SPINE SYSTEM SACRAL PLATE

K953881 is an FDA 510(k) clearance for SPINE SYSTEM SACRAL PLATE, 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 187-day FDA review.

K953881 · J.B.S., S.A. · Orthopedic device
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Feb 1996
Decision
187d
Days
Class 2
Risk

K953881 is an FDA 510(k) clearance for the SPINE SYSTEM SACRAL PLATE. 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 February 21, 1996 after a review of 187 days - an extended review 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: 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 J.B.S., S.A. devices

FDA 510(k) Submission Details - K953881

510(k) Number K953881 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 18, 1995
Decision Date February 21, 1996
Days to Decision 187 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 122d · This submission: 187d
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 K953881.
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
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915 · Depuy, Inc. · Feb 1996
SPINE FIXATION
K943827 · Danek Medical, Inc. · Feb 1996
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717 · Sofamor Danek USA,Inc. · Feb 1996