The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Fixation System-cranial, Models 80080, 80079.
| Device ID | K101835 |
| 510k Number | K101835 |
| Device Name: | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 |
| Classification | Fastener, Plate, Cranioplasty |
| Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Contact | Stephanie Fullard |
| Correspondent | Stephanie Fullard POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
| Product Code | HBW |
| CFR Regulation Number | 882.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2010-12-03 |
| Summary: | summary |