The following data is part of a premarket notification filed by Southern Medical (pty) Ltd with the FDA for Southern Transforaminal Lumbar Interbody Fusion (tlif).
| Device ID | K221182 |
| 510k Number | K221182 |
| Device Name: | Southern Transforaminal Lumbar Interbody Fusion (TLIF) |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Southern Medical (Pty) Ltd 55 Regency Drive, Route 21 Corporate Park Irene, ZA 0178 |
| Contact | Dalene Styger |
| Correspondent | Nathan Wright Empirical Technologies 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06009527200263 | K221182 | 000 |
| 06009527200102 | K221182 | 000 |
| 06009527200119 | K221182 | 000 |
| 06009527200126 | K221182 | 000 |
| 06009527200133 | K221182 | 000 |
| 06009527200140 | K221182 | 000 |
| 06009527200157 | K221182 | 000 |
| 06009527200164 | K221182 | 000 |
| 06009527200218 | K221182 | 000 |
| 06009527200225 | K221182 | 000 |
| 06009527200232 | K221182 | 000 |
| 06009527200249 | K221182 | 000 |
| 06009527200256 | K221182 | 000 |
| 06009527200096 | K221182 | 000 |