The following data is part of a premarket notification filed by Sonoma Orthopedic Products, Inc. with the FDA for Ensplint Tm Bone Screw.
| Device ID | K080778 |
| 510k Number | K080778 |
| Device Name: | ENSPLINT TM BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SONOMA ORTHOPEDIC PRODUCTS, INC. 650 LARKFIELD CENTER Santa Rosa, CA 95403 |
| Contact | Amy Conuel |
| Correspondent | Amy Conuel SONOMA ORTHOPEDIC PRODUCTS, INC. 650 LARKFIELD CENTER Santa Rosa, CA 95403 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-19 |
| Decision Date | 2008-07-10 |
| Summary: | summary |