The following data is part of a premarket notification filed by Bioplate, Inc. with the FDA for Modified Sterile Plate & Screw Kit Configurations For Use With Bioplate Titanium Fixation System.
| Device ID | K082757 |
| 510k Number | K082757 |
| Device Name: | MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM |
| Classification | Plate, Bone |
| 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 | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-19 |
| Decision Date | 2008-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M3848159150 | K082757 | 000 |
| M3848135821 | K082757 | 000 |
| M3848135831 | K082757 | 000 |
| M3848135841 | K082757 | 000 |
| M3848135851 | K082757 | 000 |
| M3848135861 | K082757 | 000 |
| M384813586US1 | K082757 | 000 |
| M3848135871 | K082757 | 000 |
| M3848135881 | K082757 | 000 |
| M384813588US1 | K082757 | 000 |
| M3848135901 | K082757 | 000 |
| M3848135911 | K082757 | 000 |
| M384813591US1 | K082757 | 000 |
| M3848135921 | K082757 | 000 |
| M384813592US1 | K082757 | 000 |
| M384813581US1 | K082757 | 000 |
| M3848135811 | K082757 | 000 |
| M3848159120 | K082757 | 000 |
| M3848120931 | K082757 | 000 |
| M3848120941 | K082757 | 000 |
| M3848135731 | K082757 | 000 |
| M384813573US1 | K082757 | 000 |
| M3848135741 | K082757 | 000 |
| M3848135751 | K082757 | 000 |
| M3848135761 | K082757 | 000 |
| M3848135771 | K082757 | 000 |
| M3848135781 | K082757 | 000 |
| M384813578US1 | K082757 | 000 |
| M3848135791 | K082757 | 000 |
| M3848135801 | K082757 | 000 |
| M384813580US1 | K082757 | 000 |
| M3848135931 | K082757 | 000 |
| M3848158851 | K082757 | 000 |
| M3848159121 | K082757 | 000 |
| M3848159151 | K082757 | 000 |
| M3848173041 | K082757 | 000 |
| M3848173071 | K082757 | 000 |
| M3848173101 | K082757 | 000 |
| M3848173111 | K082757 | 000 |
| M3848173141 | K082757 | 000 |
| M3848173201 | K082757 | 000 |
| M3848173221 | K082757 | 000 |
| M3848173231 | K082757 | 000 |
| M3848173331 | K082757 | 000 |
| M3848173631 | K082757 | 000 |
| M3848173661 | K082757 | 000 |
| M3848173681 | K082757 | 000 |
| M3848159031 | K082757 | 000 |
| M3848159021 | K082757 | 000 |
| M3848158861 | K082757 | 000 |
| M3848158871 | K082757 | 000 |
| M3848158881 | K082757 | 000 |
| M3848158891 | K082757 | 000 |
| M3848158901 | K082757 | 000 |
| M3848158911 | K082757 | 000 |
| M3848158921 | K082757 | 000 |
| M3848158931 | K082757 | 000 |
| M3848158941 | K082757 | 000 |
| M3848158951 | K082757 | 000 |
| M3848158961 | K082757 | 000 |
| M3848158981 | K082757 | 000 |
| M3848159001 | K082757 | 000 |
| M3848159011 | K082757 | 000 |
| M3848173711 | K082757 | 000 |