Cleared Traditional

K960514 - TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION)

K960514 is an FDA 510(k) clearance for TMP MANDIBULAR COMPRESSION SYSTEM (MODI..., manufactured by Anspach Fixation Systems. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K960514 · Anspach Fixation Systems · Dental device
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Apr 1996
Decision
81d
Days
Class 2
Risk

K960514 is an FDA 510(k) clearance for the TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION). Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Anspach Fixation Systems (Palm Beach Gardens, US). The FDA issued a Cleared decision on April 15, 1996 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 Anspach Fixation Systems devices

FDA 510(k) Submission Details - K960514

510(k) Number K960514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date April 15, 1996
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 127d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 237
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K960514.
OSTEOMED TRAM
K963394 · Osteomed Corp. · Nov 1996
THE BIOPLATE FIXATION SYSTEM
K961976 · Biomedics · Aug 1996
SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM
K961421 · Synthes (Usa) · Jun 1996
3I OSSEOUS FIXATION SYSTEM(S)
K960914 · Implant Innovations, Inc. · Apr 1996
SYNTHES (USA) MIDFACIAL SYSTEM
K953806 · Synthes (Usa) · Mar 1996
SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
K954385 · Synthes (Usa) · Mar 1996