The following data is part of a premarket notification filed by Theken Surgical,llc with the FDA for Bodyform Thoraco-lumbar Fixation System.
| Device ID | K983622 |
| 510k Number | K983622 |
| Device Name: | BODYFORM THORACO-LUMBAR FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | THEKEN SURGICAL,LLC 1100 NOLA AVE. Barbeton, OH 44203 -3819 |
| Contact | Lukas Eisermann |
| Correspondent | Lukas Eisermann THEKEN SURGICAL,LLC 1100 NOLA AVE. Barbeton, OH 44203 -3819 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-15 |
| Decision Date | 1998-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981048402 | K983622 | 000 |
| 10889981048273 | K983622 | 000 |
| 10889981048266 | K983622 | 000 |
| 10889981048259 | K983622 | 000 |
| 10889981048242 | K983622 | 000 |
| 10889981048235 | K983622 | 000 |
| 10889981048228 | K983622 | 000 |
| 10889981048211 | K983622 | 000 |
| 10889981048204 | K983622 | 000 |
| 10889981048198 | K983622 | 000 |
| 10889981048181 | K983622 | 000 |
| 10889981048280 | K983622 | 000 |
| 10889981048297 | K983622 | 000 |
| 10889981048396 | K983622 | 000 |
| 10889981048389 | K983622 | 000 |
| 10889981048372 | K983622 | 000 |
| 10889981048365 | K983622 | 000 |
| 10889981048358 | K983622 | 000 |
| 10889981048341 | K983622 | 000 |
| 10889981048334 | K983622 | 000 |
| 10889981048327 | K983622 | 000 |
| 10889981048310 | K983622 | 000 |
| 10889981048303 | K983622 | 000 |
| 10889981048174 | K983622 | 000 |