The following data is part of a premarket notification filed by Medical Design Llc. with the FDA for Samba Screw, 9mm Dia., 25mm Long, Sambia Screw, 9mm Dia., 30mm Long, Samba Screw 9mm Dia., 35mm Long, Samba Screw, 9mm D.
| Device ID | K121148 |
| 510k Number | K121148 |
| Device Name: | SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D |
| Classification | Screw, Fixation, Bone |
| Applicant | MEDICAL DESIGN LLC. 6709 S. MINNESOTA AVE. STE 204 Sioux Falls, SD 57108 -2593 |
| Contact | Kristi Vondra |
| Correspondent | Kristi Vondra MEDICAL DESIGN LLC. 6709 S. MINNESOTA AVE. STE 204 Sioux Falls, SD 57108 -2593 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-16 |
| Decision Date | 2012-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200119226 | K121148 | 000 |
| M364111109FD201 | K121148 | 000 |
| 11110919 | K121148 | 000 |
| 11110918 | K121148 | 000 |
| 11110917 | K121148 | 000 |
| M364111109FD161 | K121148 | 000 |
| 11110915 | K121148 | 000 |
| 11110914 | K121148 | 000 |
| 11110913 | K121148 | 000 |
| 11110911 | K121148 | 000 |
| 11110910 | K121148 | 000 |
| M364111109FD211 | K121148 | 000 |
| 11110971 | K121148 | 000 |
| 11110972 | K121148 | 000 |
| 18257200119219 | K121148 | 000 |
| 18257200119202 | K121148 | 000 |
| 18257200119196 | K121148 | 000 |
| 18257200119189 | K121148 | 000 |
| 18257200119172 | K121148 | 000 |
| 11110992 | K121148 | 000 |
| 11110991 | K121148 | 000 |
| 11110982 | K121148 | 000 |
| 11110981 | K121148 | 000 |
| 11110973 | K121148 | 000 |
| 11110912 | K121148 | 000 |