4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)

Intervertebral Fusion Device With Bone Graft, Cervical

4-WEB, INC.

The following data is part of a premarket notification filed by 4-web, Inc. with the FDA for 4-web Cervical Sts (spinal Truss System).

Pre-market Notification Details

• Device ID: K121741
• 510k Number: K121741
• Device Name: 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: 4-WEB, INC. 13540 GUILD AVE. Apple Valley, MN 55124
• Contact: Rich Jansen, Pharm, D.
• Correspondent: Rich Jansen, Pharm, D.; 4-WEB, INC. 13540 GUILD AVE. Apple Valley, MN 55124
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-13
• Decision Date: 2012-10-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00812998021888	K121741	000
00812998020324	K121741	000
00812998020317	K121741	000
00812998020300	K121741	000
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00812998021901	K121741	000