BLACKSTONE SFS PARALLEL ROD CONNECTORS— 510(k) K080407

Clearance details

Applicant

Blackstone Medical, Inc.

Product code

Code MNI

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2008-02-14

Decision date

2008-03-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Wayne, NJ, US

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• K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
• K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

• 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

Injury

641

Total

641

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 →

• Z-0896-2013 — Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new vertebral levels.Class II·Terminated·Orthofix, Inc·20130201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080407.