The following data is part of a premarket notification filed by Advanced Interventional Technology, Llc with the FDA for Swing-off Screw.
| Device ID | K130627 |
| 510k Number | K130627 |
| Device Name: | SWING-OFF SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ADVANCED INTERVENTIONAL TECHNOLOGY, LLC 7000 CASHELL MANOR CT Derwood, MD 20855 |
| Contact | Eduardo March |
| Correspondent | Eduardo March ADVANCED INTERVENTIONAL TECHNOLOGY, LLC 7000 CASHELL MANOR CT Derwood, MD 20855 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-08 |
| Decision Date | 2013-08-21 |
| Summary: | summary |