BLACKSTONE SPINAL FIXATION SYSTEM— 510(k) K994217

Name: FDA 510(k) clearance K994217
Creator: U.S. Food and Drug Administration
Published: 2000-02-28

Substantially Equivalent

Blackstone Medical, Inc.

FDA 510(k) clearance K994217 for BLACKSTONE SPINAL FIXATION SYSTEM, Substantially Equivalent on 2000-02-28. Applicant: Blackstone Medical, Inc.. Device class: 2.

Clearance details

Applicant: Blackstone Medical, Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1999-12-15
Decision date: 2000-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Springfield, MA, US

Download summary PDF View on FDA.gov ↗

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K162189 — ANAX 5.5 Spinal System2016-08-30

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 MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.