The following data is part of a premarket notification filed by Graham Medical Technologies, L.l.c. Dba Gramedica with the FDA for Osteo-wedge Ii ® Open Wedge Bone Locking Plate System.
| Device ID | K162179 |
| 510k Number | K162179 |
| Device Name: | Osteo-WEDGE II ® Open Wedge Bone Locking Plate System |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-04 |
| Decision Date | 2017-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M621GM503030 | K162179 | 000 |
| M621GM503240 | K162179 | 000 |
| M621GM503210 | K162179 | 000 |
| M621GM503180 | K162179 | 000 |
| M621GM503150 | K162179 | 000 |
| M621GM503120 | K162179 | 000 |
| M621GM503090 | K162179 | 000 |
| M621GM503060 | K162179 | 000 |
| M621GM503000 | K162179 | 000 |
| M621GM160040 | K162179 | 000 |
| M621GM503270 | K162179 | 000 |
| M621GM503300 | K162179 | 000 |
| M621GM504030 | K162179 | 000 |
| M621GM504300 | K162179 | 000 |
| M621GM504270 | K162179 | 000 |
| M621GM504240 | K162179 | 000 |
| M621GM504210 | K162179 | 000 |
| M621GM504180 | K162179 | 000 |
| M621GM504150 | K162179 | 000 |
| M621GM504120 | K162179 | 000 |
| M621GM504090 | K162179 | 000 |
| M621GM504060 | K162179 | 000 |
| M621GM160030 | K162179 | 000 |