PIONEER LUMBAR PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Lumbar Plate System.

Pre-market Notification Details

• Device ID: K090222
• 510k Number: K090222
• Device Name: PIONEER LUMBAR PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627
• Contact: Jonathan M Gilbert
• Correspondent: Jonathan M Gilbert; PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-01-30
• Decision Date: 2009-04-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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