UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

BLACKSTONE MEDICAL, INC.

The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Unity Lx Anterolateral Lumbar Plate Fixation System.

Pre-market Notification Details

• Device ID: K061229
• 510k Number: K061229
• Device Name: UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne, NJ 07470
• Contact: Martin Sprunck
• Correspondent: Martin Sprunck; BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne, NJ 07470
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-05-02
• Decision Date: 2006-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18257200081134	K061229	000
18257200081127	K061229	000
18257200032594	K061229	000