The following data is part of a premarket notification filed by Otis Biotech Co., Ltd with the FDA for Ulc Spinal Pedicle Screw System.
| Device ID | K083077 |
| 510k Number | K083077 |
| Device Name: | ULC SPINAL PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | OTIS BIOTECH CO., LTD 514, 2-BA BLOCK, JUNGWANG-DONG SIHMA INDUSTRIAL COMPLEX Sihung City, Kyonggi-do, KR 429-450 |
| Contact | Jisuk Yoo |
| Correspondent | Jisuk Yoo OTIS BIOTECH CO., LTD 514, 2-BA BLOCK, JUNGWANG-DONG SIHMA INDUSTRIAL COMPLEX Sihung City, Kyonggi-do, KR 429-450 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-16 |
| Decision Date | 2009-10-26 |
| Summary: | summary |