System, Facet Screw Spinal Device

Device Code: 4730

Product Code(s): MRW

Device Classification Information

• Device Type ID: 4730
• Device Name: System, Facet Screw Spinal Device
• Review Panel: Orthopedic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Orthopedic Devices (DOD); Posterior Spine Devices Branch (PSDB)
• Submission Type: 510(k)
• FDA Device Classification: Class Unclassified Medical Device
• Product Code: MRW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 4730
• Device: System, Facet Screw Spinal Device
• Product Code: MRW

Premarket Reviews
Manufacturer	Decision
FACET-LINK, INC.
	SUBSTANTIALLY EQUIVALENT	1
LDR SPINE USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	2
Adverse Event Without Identified Device Or Use Problem	2
Misassembled	1
Loose Or Intermittent Connection	1
Device Handling Problem	1
Total Device Problems	7

TPLC Last Update: 2019-04-02 20:54:37