The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Rapidflap Ls Cranial Flap Fixation System.
| Device ID | K130309 |
| 510k Number | K130309 |
| Device Name: | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM |
| Classification | Cover, Burr Hole |
| Applicant | BIOMET MICROFIXATION 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Contact | Christine Scifert |
| Correspondent | Christine Scifert BIOMET MICROFIXATION 3416 ROXEE RUN COVE Bartlett, TN 38133 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2013-06-17 |
| Summary: | summary |