The following data is part of a premarket notification filed by Synthes Usa Products Llc with the FDA for Depuy Synthes T-pal Ti Spacer.
| Device ID | K151276 |
| 510k Number | K151276 |
| Device Name: | DePuy Synthes T-PAL Ti Spacer |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SYNTHES USA PRODUCTS LLC 325 Paramount Drive Raynham, MA 02767 |
| Contact | Eric Zhu |
| Correspondent | Eric Zhu SYNTHES USA PRODUCTS LLC 325 Paramount Drive Raynham, MA 02767 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-13 |
| Decision Date | 2015-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98104812216S0 | K151276 | 000 |
| H98104812207S0 | K151276 | 000 |
| H98104812015S0 | K151276 | 000 |
| H98104812011S0 | K151276 | 000 |
| H98104812007S0 | K151276 | 000 |
| H98104812017S0 | K151276 | 000 |
| 10705034817040 | K151276 | 000 |
| H98104812008S0 | K151276 | 000 |
| H98104812217S00 | K151276 | 000 |
| 07611819416802 | K151276 | 000 |
| 07611819414624 | K151276 | 000 |
| 07611819414600 | K151276 | 000 |
| H98104812208S00 | K151276 | 000 |
| H98104812209S0 | K151276 | 000 |
| H98104812214S0 | K151276 | 000 |
| H98104812016S0 | K151276 | 000 |
| H98104812215S0 | K151276 | 000 |
| H98104812213S0 | K151276 | 000 |
| H98104812014S0 | K151276 | 000 |
| H98104812013S0 | K151276 | 000 |
| H98104812012S0 | K151276 | 000 |
| H98104812010S0 | K151276 | 000 |
| H98104812212S0 | K151276 | 000 |
| H98104812211S0 | K151276 | 000 |
| H98104812210S0 | K151276 | 000 |
| 07611819405813 | K151276 | 000 |