The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Lospa Is Pedicle Screw (monoaxial & Polyaxial), Lospa Is Rod- Straight (standard), Lospa Is Rod- Pre Bent (standard & Bu.
| Device ID | K132644 |
| 510k Number | K132644 |
| Device Name: | LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | CORENTEC CO., LTD 8TH FLOOR CHUNGHO TOWER 748-1 BANPO 1 DONG Seocho Gu, Seoul, KP 137-040 |
| Contact | J.s. Daniel |
| Correspondent | J.s. Daniel CORENTEC CO., LTD 8TH FLOOR CHUNGHO TOWER 748-1 BANPO 1 DONG Seocho Gu, Seoul, KP 137-040 |
| Product Code | MNI |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2013-09-19 |
| Summary: | summary |