The following data is part of a premarket notification filed by Skeletal Kinetics, Llc with the FDA for Skaffold Cis.
| Device ID | K111538 |
| 510k Number | K111538 |
| Device Name: | SKAFFOLD CIS |
| Classification | Wax, Bone |
| Applicant | SKELETAL KINETICS, LLC 10201 BUBB RD. Cupertino, CA 95014 -4167 |
| Contact | Christine Kuo |
| Correspondent | Christine Kuo SKELETAL KINETICS, LLC 10201 BUBB RD. Cupertino, CA 95014 -4167 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2011-10-25 |
| Summary: | summary |