The following data is part of a premarket notification filed by Implex Corp. with the FDA for Modification To The Trabecular Metal Glenoid - Bigliani/flatow The Complete Shoulder Solution.
| Device ID | K031449 |
| 510k Number | K031449 |
| Device Name: | MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | Robert A Poggie |
| Correspondent | Robert A Poggie IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-07 |
| Decision Date | 2003-09-23 |
| Summary: | summary |