The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & Accessories.
| Device ID | K072528 |
| 510k Number | K072528 |
| Device Name: | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES |
| Classification | Plate, Bone |
| Applicant | PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2007-12-28 |
| Summary: | summary |