ARENA-C

Intervertebral Fusion Device With Bone Graft, Cervical

SPINEFRONTIER, INC.

The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Arena-c.

Pre-market Notification Details

• Device ID: K141337
• 510k Number: K141337
• Device Name: ARENA-C
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: SPINEFRONTIER, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918
• Contact: Meredith May Ms, Rac
• Correspondent: Meredith May Ms, Rac; SPINEFRONTIER, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-05-21
• Decision Date: 2014-09-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00190361036296	K141337	000
00190361036531	K141337	000
00190361036548	K141337	000
00190361036555	K141337	000
00190361036562	K141337	000
00190361036654	K141337	000
00190361036661	K141337	000
00190361036678	K141337	000
00190361036685	K141337	000
00190361036692	K141337	000
00190361036708	K141337	000
00190361036715	K141337	000
00190361036722	K141337	000
00190361036739	K141337	000
00190361036524	K141337	000
00190361036517	K141337	000
00190361036302	K141337	000
00190361036319	K141337	000
00190361036326	K141337	000
00190361036418	K141337	000
00190361036425	K141337	000
00190361036432	K141337	000
00190361036449	K141337	000
00190361036456	K141337	000
00190361036463	K141337	000
00190361036470	K141337	000
00190361036487	K141337	000
00190361036494	K141337	000
00190361036500	K141337	000
00190361036746	K141337	000
00190361036753	K141337	000
00190361036913	K141337	000
00190361036920	K141337	000
00190361036937	K141337	000
00190361036944	K141337	000
00190361036951	K141337	000
00190361036968	K141337	000
00190361036975	K141337	000
00190361036982	K141337	000
00190361036999	K141337	000
00190361037002	K141337	000
00190361037019	K141337	000
00190361037026	K141337	000
00190361037033	K141337	000
00190361036906	K141337	000
00190361036890	K141337	000
00190361036760	K141337	000
00190361036777	K141337	000
00190361036784	K141337	000
00190361036791	K141337	000
00190361036807	K141337	000
00190361036814	K141337	000
00190361036821	K141337	000
00190361036838	K141337	000
00190361036845	K141337	000
00190361036852	K141337	000
00190361036869	K141337	000
00190361036876	K141337	000
00190361036883	K141337	000
00190361037040	K141337	000