HG MEDICAL USA, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3032588003 | 3032588003 | HG MEDICAL USA, LLC | 1 | N | 2026-01-01 | 701 S Waverly Rd Ste 350 Holland MI US 49423 |
| 3011654983 | 3011654983 | HG Medical USA, LLC | 1 | Y | 2020-04-25 | 810 Memorial Blvd Huntington WV US 25701 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 184646 | 1417969530 | K181820 | Medline Unite Mini Plates and Screws | HRS | 2018-11-01 |
| 184646 | 1531228271 | K170782 | Medline UNITE® Snap-Off Screws | HWC | 2017-08-18 |
| 184646 | 1972688100 | K162829 | Medline UNITE® Ankle Fracture Plating System | HRS | 2016-12-09 |
| 184646 | 1342897893 | K152306 | MotoBand¿ CP Implant System | HRS | 2015-12-11 |
| 184646 | 1991290675 | K151235 | Medline Foot Plates and Screws | HRS | 2015-08-06 |
| 184646 | 1262482595 | K143717 | Treace Medical Concepts(TMC) Plating System | HRS | 2015-03-19 |
| 184646 | 1803667497 | K140397 | PARALOCK PLATING SYSTEM / TUFFNEK SCREW | HRS | 2014-04-17 |
| 184646 | 1820189758 | K130319 | MEDLINE CANNULATED SCREW | HWC | 2013-05-31 |
| 184646 | 1474331233 | K124027 | MONSTER SCREW SYSTEM | HWC | 2013-04-05 |
| 184646 | 1520260583 | K111253 | ARTHREX DISTAL EXTREMITY PLATE SYSTEM | HRS | 2011-08-02 |
| 184646 | 1736666199 | K102429 | ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW | HRS | 2010-11-23 |
| 184646 | 1303875752 | K094037 | TC PLATING SYSTEM | HRS | 2010-03-10 |
| 184646 | 1177726049 | K090692 | ORTHOLOC 2.0/2.4 PLATE SYSTEM | HRS | 2009-05-08 |
| 184646 | 1096937901 | K061808 | DARCO LOCKING BONE PLATE SYSTEM | HRS | 2006-08-17 |
| 184646 | 1617987730 | K043583 | CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 | HWC | 2005-01-26 |
| 184646 | 1057444003 | K040938 | RADIAL NAIL SYSTEM | HRS | 2004-07-01 |
| 331517 | 1087911274 | ||||
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| 331517 | 2045825290 |