MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM— 510(k) K030241

Name: FDA 510(k) clearance K030241
Creator: U.S. Food and Drug Administration
Published: 2003-02-21

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K030241 for MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM, Substantially Equivalent on 2003-02-21. Applicant: Blackstone Medical, Inc.. Device class: 2.

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code KWP
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2003-01-23
Decision date: 2003-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Springfield, MA, US

Download summary PDF View on FDA.gov ↗

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K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

More clearances from Blackstone Medical, Inc.

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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 KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.