The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Scs Dt-02 Transverse Connector.
| Device ID | K003823 |
| 510k Number | K003823 |
| Device Name: | SCS DT-02 TRANSVERSE CONNECTOR |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ORTHOTEC, L.L.C. 546 HILLGREEN DR. Beverly Hills, CA 90212 -4110 |
| Contact | Patrick Bertranou |
| Correspondent | Patrick Bertranou ORTHOTEC, L.L.C. 546 HILLGREEN DR. Beverly Hills, CA 90212 -4110 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-11 |
| Decision Date | 2001-07-11 |