The following data is part of a premarket notification filed by Graham Medical Technologies, L.l.c. with the FDA for Hyprocure Subtalar Implant System.
| Device ID | K042030 |
| 510k Number | K042030 |
| Device Name: | HYPROCURE SUBTALAR IMPLANT SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | GRAHAM MEDICAL TECHNOLOGIES, L.L.C. 45700 SCHOENHERR ROAD Shelby Township, MI 48315 |
| Contact | Michael Graham |
| Correspondent | Michael Graham GRAHAM MEDICAL TECHNOLOGIES, L.L.C. 45700 SCHOENHERR ROAD Shelby Township, MI 48315 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-28 |
| Decision Date | 2004-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M621HYPINSTRAY0 | K042030 | 000 |
| M621CP1506FG0 | K042030 | 000 |
| M621CP1507FG0 | K042030 | 000 |
| M621CP1508FG0 | K042030 | 000 |
| M621CP1509FG0 | K042030 | 000 |
| M621CP1510FG0 | K042030 | 000 |
| M621HD5FG0 | K042030 | 000 |
| M621HYP050 | K042030 | 000 |
| M621HYP060 | K042030 | 000 |
| M621HYP070 | K042030 | 000 |
| M621HYP080 | K042030 | 000 |
| M621HYP090 | K042030 | 000 |
| M621HYP100 | K042030 | 000 |
| M621HYPGUIDEWIRES0 | K042030 | 000 |
| M621CP1505FG0 | K042030 | 000 |