The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Slim-loc System.
| Device ID | K013877 |
| 510k Number | K013877 |
| Device Name: | CODMAN SLIM-LOC SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Kathryn Wunder |
| Correspondent | Kathryn Wunder Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2001-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034063843 | K013877 | 000 |
| 10705034063645 | K013877 | 000 |
| 10705034063652 | K013877 | 000 |
| 10705034063669 | K013877 | 000 |
| 10705034063676 | K013877 | 000 |
| 10705034063683 | K013877 | 000 |
| 10705034063690 | K013877 | 000 |
| 10705034063706 | K013877 | 000 |
| 10705034063751 | K013877 | 000 |
| 10705034063768 | K013877 | 000 |
| 10705034063782 | K013877 | 000 |
| 10705034063799 | K013877 | 000 |
| 10705034063805 | K013877 | 000 |
| 10705034063812 | K013877 | 000 |
| 10705034063829 | K013877 | 000 |
| 10705034063836 | K013877 | 000 |
| 10705034063775 | K013877 | 000 |