The following data is part of a premarket notification filed by Graham Medical Technologies, L.l.c. Dba Gramedica with the FDA for Hyprocure Ii.
| Device ID | K142534 |
| 510k Number | K142534 |
| Device Name: | HyProCure II |
| Classification | Screw, Fixation, Bone |
| Applicant | Graham Medical Technologies, L.L.C. Dba GraMedica 16137 LEONE DRIVE Macomb, MI 48042 |
| Contact | Angela Recchia |
| Correspondent | Linda Braddon SECURE BIOMED EVALUATIONS 7828 HICKORY FLAT HIGHWAY Suite 120 Woodstock, GA 30188 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-09 |
| Decision Date | 2014-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M621HYPIITS120 | K142534 | 000 |
| M621HYPII070 | K142534 | 000 |
| M621HYPII080 | K142534 | 000 |
| M621HYPII090 | K142534 | 000 |
| M621HYPII100 | K142534 | 000 |
| M621HYPII110 | K142534 | 000 |
| M621HYPII120 | K142534 | 000 |
| M621HYPII50 | K142534 | 000 |
| M621HYPIIINSTRAY0 | K142534 | 000 |
| M621HYPIIPS0 | K142534 | 000 |
| M621HYPIITS060 | K142534 | 000 |
| M621HYPIITS070 | K142534 | 000 |
| M621HYPIITS080 | K142534 | 000 |
| M621HYPIITS090 | K142534 | 000 |
| M621HYPIITS100 | K142534 | 000 |
| M621HYPIITS110 | K142534 | 000 |
| M621HYPII060 | K142534 | 000 |