The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for N8tive Acl Anatomic Reconstruction System, N8tive Acl Femoral Implant, N8tive Acl Tibial Implant, Various Class I Ancill.
| Device ID | K133606 |
| 510k Number | K133606 |
| Device Name: | N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Contact | Mitchell Dhority |
| Correspondent | Mitchell Dhority ARTHROCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-25 |
| Decision Date | 2014-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470011074 | K133606 | 000 |
| 00817470011005 | K133606 | 000 |
| 00817470010992 | K133606 | 000 |