The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Mofication To: Modified Plate Design For Bioplate Zip Craniotomy Fixation.
| Device ID | K082175 |
| 510k Number | K082175 |
| Device Name: | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 -4310 |
| Contact | Jesus T Farinas |
| Correspondent | Jesus T Farinas BIOPLATE, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 -4310 |
| Product Code | GXN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-01 |
| Decision Date | 2008-08-13 |
| Summary: | summary |