Cleared Traditional

K033702 - BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM

K033702 is an FDA 510(k) clearance for BLACKSTONE PEEK VERTEBRAL BODY REPLACEM..., manufactured by Blackstone Medical, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K033702 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
127d
Days
Class 2
Risk

K033702 is an FDA 510(k) clearance for the BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on March 31, 2004 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Blackstone Medical, Inc. devices

FDA 510(k) Submission Details - K033702

510(k) Number K033702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2003
Decision Date March 31, 2004
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 267
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K033702.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536 · Medtronic Sofamor Danek · May 2004
EBI ESL SPINE SPACER SYSTEM
K040482 · Ebi, L.P. · Apr 2004
MODIFICATION TO GEO STRUCTURE
K040168 · Interpore Cross Intl. · Apr 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · Globus Medical, Inc. · Mar 2004
MODIFICATION TO VERTE-STACK
K040422 · Medtronic Sofamor Danek · Mar 2004
SPINAL CONCEPTS INC. CADENCE AND TRAXIS
K033517 · Spinal Concepts, Inc. · Feb 2004