BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS— 510(k) K041939

Name: FDA 510(k) clearance K041939
Creator: U.S. Food and Drug Administration
Published: 2004-08-17

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K041939 for BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS, Substantially Equivalent on 2004-08-17. Applicant: Blackstone Medical, Inc.. Device class: 2.

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2004-07-19
Decision date: 2004-08-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Springfield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQP

view all

K261810 — Vertiwedge® Intraosseous System2026-07-31
K261031 — POSEIDON ST2026-07-10
K253158 — VyBrate VBR System2026-01-07
K241468 — Vertiwedge® Intraosseous System2024-11-07
K232790 — KONG®-TL VBR System and KONG® C VBR System2024-04-04

More clearances from Blackstone Medical, Inc.

view all

K093926 — FIREBIRD SPINAL FIXATION SYSTEM2010-07-28
K100614 — HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES2010-05-04
K092624 — FIREBIRD SPINAL FIXATION SYSTEM2009-09-25
K082797 — BLACKSTONE PEDICLE SCREW SYSTEM2008-10-17
K081684 — BLACKSTONE PEDICLE SCREW SYSTEM2008-09-15

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.