The following data is part of a premarket notification filed by Implex Corp. with the FDA for Implex Screw And Washer System.
| Device ID | K982751 |
| 510k Number | K982751 |
| Device Name: | IMPLEX SCREW AND WASHER SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Robert Poggie |
| Correspondent | Robert Poggie IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1999-02-01 |
| Summary: | summary |