The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Modified Plate Design For Bioplate Zip Craniotomy Fixation System.
| Device ID | K070901 |
| 510k Number | K070901 |
| Device Name: | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM |
| 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 | 2007-04-02 |
| Decision Date | 2007-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M3848135960 | K070901 | 000 |
| M3848134970 | K070901 | 000 |
| M3848134980 | K070901 | 000 |
| M3848135161 | K070901 | 000 |
| M3848135171 | K070901 | 000 |
| M3848135181 | K070901 | 000 |
| M3848135940 | K070901 | 000 |
| M3848135950 | K070901 | 000 |
| M384813595US0 | K070901 | 000 |
| M3848134960 | K070901 | 000 |