The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Micro Dynamic Mesh.
| Device ID | K983528 |
| 510k Number | K983528 |
| Device Name: | MICRO DYNAMIC MESH |
| Classification | Plate, Bone |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Vivian Kelly |
| Correspondent | Vivian Kelly HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-08 |
| Decision Date | 1998-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154731169 | K983528 | 000 |
| 04546540237675 | K983528 | 000 |
| 04546540237668 | K983528 | 000 |
| 04546540237651 | K983528 | 000 |
| 04546540237644 | K983528 | 000 |
| 04546540237637 | K983528 | 000 |
| 04546540237620 | K983528 | 000 |
| 04546540237613 | K983528 | 000 |
| 04546540237606 | K983528 | 000 |
| 04546540237590 | K983528 | 000 |
| 04546540237583 | K983528 | 000 |
| 04546540237682 | K983528 | 000 |
| 04546540684868 | K983528 | 000 |
| 04546540684875 | K983528 | 000 |
| 07613154730582 | K983528 | 000 |
| 07613154639298 | K983528 | 000 |
| 07613154556625 | K983528 | 000 |
| 07613153170389 | K983528 | 000 |
| 07613153170372 | K983528 | 000 |
| 07613153170341 | K983528 | 000 |
| 07613153170334 | K983528 | 000 |
| 04546540685049 | K983528 | 000 |
| 04546540685032 | K983528 | 000 |
| 04546540685025 | K983528 | 000 |
| 04546540237576 | K983528 | 000 |