Cleared Traditional

MOSS MIAMI SPINAL SYSTEM (K962628) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962628 · Depuy, Inc. · Orthopedic device
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Mar 1997
Decision
256d
Days
Class 2
Risk

K962628 is an FDA 510(k) clearance for the MOSS MIAMI SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 18, 1997 after a review of 256 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Depuy, Inc. devices

Submission Details

510(k) Number K962628 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 05, 1996
Decision Date March 18, 1997
Days to Decision 256 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
134d slower than avg
Panel avg: 122d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 98
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K962628.
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358 · Synthes (Usa) · Apr 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K974573 · Depuy, Inc. · Feb 1998
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024 · Depuy, Inc. · Mar 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · Depuy, Inc. · Mar 1997
HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM
K962314 · Osteonics Corp. · Dec 1996
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348 · Depuy, Inc. · Feb 1996