Cleared Traditional

K973586 - SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II

K973586 is an FDA 510(k) clearance for SPINAL CONCEPTS, manufactured by Spinal Concepts, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K973586 · Spinal Concepts, Inc. · Orthopedic device
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Nov 1997
Decision
46d
Days
Class 2
Risk

K973586 is an FDA 510(k) clearance for the SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on November 7, 1997 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Spinal Concepts, Inc. devices

FDA 510(k) Submission Details - K973586

510(k) Number K973586 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 22, 1997
Decision Date November 07, 1997
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 974
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K973586.
DRG LARGE SCREW SYSTEM
K973810 · Dolphin Medical Technologies, Inc. · Jan 1998
ORTHOPEDIC SCREW SYSTEM
K972217 · Ferguson Medical · Nov 1997
THE CORIFIX LIGAMENT ANCHOR
K973005 · Corin USA · Nov 1997
LEIBINGER SELF-DRILLING SCREW
K970912 · Howmedica Leibinger, Inc. · Oct 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · Depuy, Inc. · Oct 1997
ACUFEX SCREW CANNULA
K972599 · Smith & Nephew Endoscopy, Inc. · Sep 1997