IMPIX MANTA CERVICAL INTERBODY DEVICE

Intervertebral Fusion Device With Bone Graft, Cervical

MEDICREA

The following data is part of a premarket notification filed by Medicrea with the FDA for Impix Manta Cervical Interbody Device.

Pre-market Notification Details

• Device ID: K100484
• 510k Number: K100484
• Device Name: IMPIX MANTA CERVICAL INTERBODY DEVICE
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: MEDICREA 1001 OAKWOOD BLVD Round Rock, TX 78681
• Contact: J.d. Webb
• Correspondent: J.d. Webb; MEDICREA 1001 OAKWOOD BLVD Round Rock, TX 78681
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-18
• Decision Date: 2010-03-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03613720230625	K100484	000
03613720230755	K100484	000
03613720230762	K100484	000
03613720230779	K100484	000
03613720230786	K100484	000
03613720230793	K100484	000
03613720230809	K100484	000
03613720230816	K100484	000
03613720230823	K100484	000
03613720230830	K100484	000
03613720230847	K100484	000
03613720230854	K100484	000
03613720230748	K100484	000
03613720230731	K100484	000
03613720230632	K100484	000
03613720230618	K100484	000
03613720230649	K100484	000
03613720230656	K100484	000
03613720230663	K100484	000
03613720230670	K100484	000
03613720230687	K100484	000
03613720230694	K100484	000
03613720230700	K100484	000
03613720230717	K100484	000
03613720230724	K100484	000
03613720230861	K100484	000
03613720230878	K100484	000
03613720233275	K100484	000
03613720233305	K100484	000
03613720233336	K100484	000
03613720233367	K100484	000
03613720233466	K100484	000
03613720233497	K100484	000
03613720233527	K100484	000
03613720233558	K100484	000
03613720233657	K100484	000
03613720233688	K100484	000
03613720233718	K100484	000
03613720231004	K100484	000
03613720230991	K100484	000
03613720230885	K100484	000
03613720230892	K100484	000
03613720230908	K100484	000
03613720230915	K100484	000
03613720230922	K100484	000
03613720230939	K100484	000
03613720230946	K100484	000
03613720230953	K100484	000
03613720230960	K100484	000
03613720230977	K100484	000
03613720230984	K100484	000
03613720233749	K100484	000