The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes T-pal Spacer.
| Device ID | K100089 |
| 510k Number | K100089 |
| Device Name: | SYNTHES T-PAL SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Heather Guerin |
| Correspondent | Heather Guerin SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-12 |
| Decision Date | 2010-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981088122170 | K100089 | 000 |
| H981088120160 | K100089 | 000 |
| H981088120150 | K100089 | 000 |
| H981088120140 | K100089 | 000 |
| H981088120130 | K100089 | 000 |
| H981088120120 | K100089 | 000 |
| H981088120110 | K100089 | 000 |
| H981088120100 | K100089 | 000 |
| H981088120090 | K100089 | 000 |
| H981088120080 | K100089 | 000 |
| H981088120170 | K100089 | 000 |
| H981088122070 | K100089 | 000 |
| H981088122160 | K100089 | 000 |
| H981088122150 | K100089 | 000 |
| H981088122140 | K100089 | 000 |
| H981088122130 | K100089 | 000 |
| H981088122120 | K100089 | 000 |
| H981088122110 | K100089 | 000 |
| H981088122100 | K100089 | 000 |
| H981088122090 | K100089 | 000 |
| H981088122080 | K100089 | 000 |
| H981088120070 | K100089 | 000 |