Cleared Traditional

K930515 - ALPHA SPINAL SYSTEM

K930515 is an FDA 510(k) clearance for ALPHA SPINAL SYSTEM, manufactured by Alphatec Mfg., Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 513-day FDA review.

K930515 · Alphatec Mfg., Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
513d
Days
Class 2
Risk

K930515 is an FDA 510(k) clearance for the ALPHA SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Concord, US). The FDA issued a Cleared decision on June 29, 1994 after a review of 513 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

FDA 510(k) Submission Details - K930515

510(k) Number K930515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 01, 1993
Decision Date June 29, 1994
Days to Decision 513 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
391d slower than avg
Panel avg: 122d · This submission: 513d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

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 410
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K930515.
J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE
K935113 · J.B.S., S.A. · Oct 1994
STRYKER 2S SPINAL SYSTEM
K930009 · Stryker Corp. · Sep 1994
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · Depuy, Inc. · Jul 1994
D-C-S SYSTEM
K930657 · Pina-Vertriebs · Jun 1994
GDLH VARIABLE ANGLE CONNECTOR
K934582 · Danek Group, Inc. · Jun 1994
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994