The following data is part of a premarket notification filed by Elite Surgical Supplies (pty) Ltd. with the FDA for Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif System.
| Device ID | K130274 |
| 510k Number | K130274 |
| Device Name: | BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ELITE SURGICAL SUPPLIES (PTY) LTD. 184 BESSEMER ROAD Pretoria West Indu., Gauteng, ZA 0183 |
| Contact | John O'toole |
| Correspondent | John O'toole ELITE SURGICAL SUPPLIES (PTY) LTD. 184 BESSEMER ROAD Pretoria West Indu., Gauteng, ZA 0183 |
| Product Code | MAX |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-04 |
| Decision Date | 2013-10-29 |
| Summary: | summary |