The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Thoracolumbar Spine Locking Plate (tslp).
| Device ID | K020244 |
| 510k Number | K020244 |
| Device Name: | SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES SPINE 1380 ENTERPRISE DR. West Chester, PA 19380 |
| Contact | Vikki M Hoffman |
| Correspondent | Vikki M Hoffman SYNTHES SPINE 1380 ENTERPRISE DR. West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-24 |
| Decision Date | 2002-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814895120 | K020244 | 000 |
| H9814894700 | K020244 | 000 |
| H9814894660 | K020244 | 000 |
| H9814894630 | K020244 | 000 |
| H9814894610 | K020244 | 000 |
| H9814894580 | K020244 | 000 |
| H9814894560 | K020244 | 000 |
| H9814894530 | K020244 | 000 |
| H9814894500 | K020244 | 000 |
| H9814894460 | K020244 | 000 |
| H9814894430 | K020244 | 000 |
| H9814894740 | K020244 | 000 |
| H9814894750 | K020244 | 000 |
| H9814895100 | K020244 | 000 |
| H9814895060 | K020244 | 000 |
| H9814895000 | K020244 | 000 |
| H9814894970 | K020244 | 000 |
| H9814894930 | K020244 | 000 |
| H9814894900 | K020244 | 000 |
| H9814894890 | K020244 | 000 |
| H9814894870 | K020244 | 000 |
| H9814894830 | K020244 | 000 |
| H9814894800 | K020244 | 000 |
| H9814894400 | K020244 | 000 |