The following data is part of a premarket notification filed by Trans1 Incorporated with the FDA for Trans1 Lateral Intervertebral Fusion Device, T.
| Device ID | K100210 |
| 510k Number | K100210 |
| Device Name: | TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington, NC 28412 |
| Contact | Cheryl Wagoner |
| Correspondent | Cheryl Wagoner TRANS1 INCORPORATED 411 LANDMARK DR. Wilmington, NC 28412 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996177207 | K100210 | 000 |
| 00840996181310 | K100210 | 000 |
| 00840996181365 | K100210 | 000 |
| 00840996181372 | K100210 | 000 |
| 00840996181389 | K100210 | 000 |
| 00840996181396 | K100210 | 000 |
| 00840996177160 | K100210 | 000 |
| 00840996177177 | K100210 | 000 |
| 00840996177184 | K100210 | 000 |
| 00840996177191 | K100210 | 000 |
| 00840996181303 | K100210 | 000 |