The following data is part of a premarket notification filed by Depuy Synthes Spine with the FDA for Depuy Synthes T-pal Spacer System.
| Device ID | K181231 |
| 510k Number | K181231 |
| Device Name: | DePuy Synthes T-PAL Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | DePuy Synthes Spine 325 Paramount Drive Raynham, MA 02767 |
| Contact | Heta Shah |
| Correspondent | Rozanne Shirley DePuy Synthes 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-09 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612334143785 | K181231 | 000 |
| 07612334143778 | K181231 | 000 |