The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Leforte Neurosystem Bone Screw.
| Device ID | K091686 |
| 510k Number | K091686 |
| Device Name: | LEFORTE NEUROSYSTEM BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | JEIL MEDICAL CORPORATION 215 S. STATE STREET STE: 100B Salt Lake City, UT 84111 |
| Contact | Shin Kuk Yoo |
| Correspondent | Shin Kuk Yoo JEIL MEDICAL CORPORATION 215 S. STATE STREET STE: 100B Salt Lake City, UT 84111 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711CR19040 | K091686 | 000 |
| 08809265155089 | K091686 | 000 |
| 08809265152125 | K091686 | 000 |
| 08809265152118 | K091686 | 000 |
| 08809265152026 | K091686 | 000 |
| 08809265151081 | K091686 | 000 |
| 08809265150169 | K091686 | 000 |
| 08809265150152 | K091686 | 000 |
| 08809265150138 | K091686 | 000 |
| 08809265150121 | K091686 | 000 |
| 08809265150046 | K091686 | 000 |
| 08809265155140 | K091686 | 000 |
| 08809265155195 | K091686 | 000 |
| 08809265155218 | K091686 | 000 |
| M711CR16050 | K091686 | 000 |
| M711CR16040 | K091686 | 000 |
| M711CR16030 | K091686 | 000 |
| 08809265155386 | K091686 | 000 |
| 08809265155355 | K091686 | 000 |
| 08809265155348 | K091686 | 000 |
| 08809265155331 | K091686 | 000 |
| 08809265155324 | K091686 | 000 |
| 08809265155317 | K091686 | 000 |
| 08809265155300 | K091686 | 000 |
| 08806390800242 | K091686 | 000 |