Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K102845
MAHE FIXATION PLATE AND SCREW SYSTEM · Mahe Medical GmbH · decided 2011-05-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Key Surgical K-Wires and Steinmann Pins | KI-71-124 | KEY SURGICAL, INC. | HRS HTY HWC | 00849771012436 |
| HNM MEDICAL | HKW-18-090011 | HNM STAINLESS, LLC. | HTY | 00842962105986 |
| LYNX | HTR-02-510214 | HNM TOTAL RECON LLC | HRS | 00841742111803 |
| (unnamed) | K-Wires and Steinmann Pins | KEY SURGICAL, INC. | HRS HTY HWC | 10849771050268 |
| (unnamed) | K-Wires and Steinmann Pin | KEY SURGICAL, INC. | HRS HTY HWC | 10849771049965 |
| (unnamed) | K-Wires and Steinmann Pins | KEY SURGICAL, INC. | HRS HTY HWC | 10849771049941 |
| Key Surgical K-Wires and Steinmann Pins | KI-71-768 | KEY SURGICAL, INC. | HTY | 00849771015598 |
| Key Surgical K-Wires and Steinmann Pins | KI-71-633 | KEY SURGICAL, INC. | HTY | 00849771015000 |
| Key Surgical K-Wires and Steinmann Pins | KI-71-208 | KEY SURGICAL, INC. | HRS HTY HWC | 00849771012764 |
| Key Surgical K-Wires and Steinmann Pins | KI-71-121 | KEY SURGICAL, INC. | HRS HTY HWC | 00849771012405 |
| Key Surgical K-Wires and Steinmann Pins | KI-71-030 | KEY SURGICAL, INC. | HRS HTY HWC | 00849771012139 |
| POLARIS | HTR-02-031026 | HNM TOTAL RECON LLC | HWC | 00841742113500 |
| LYNX | HTR-02-800885 | HNM TOTAL RECON LLC | HRS | 00841742113067 |
| LYNX | HTR-02-110307 | HNM TOTAL RECON LLC | HRS | 00841742112718 |
| LYNX | HTR-02-070912 | HNM TOTAL RECON LLC | HRS | 00841742112473 |
| LYNX | HTR-02-070412 | HNM TOTAL RECON LLC | HWC | 00841742111322 |
| (unnamed) | K-Wires and Steinmann Pin | KEY SURGICAL, INC. | HRS HTY HWC | 10849771049972 |
| (unnamed) | K-Wires and Steinmann Pin | KEY SURGICAL, INC. | HRS HTY HWC | 10849771049859 |
| Key Surgical K-Wires and Steinmann Pins | KI-71-762 | KEY SURGICAL, INC. | HTY | 00849771015536 |
| HNM MEDICAL | HKW-12-040014 | HNM STAINLESS, LLC. | HTY | 00842962105450 |
| LYNX | HTR-02-810555 | HNM TOTAL RECON LLC | HRS | 00841742113135 |
| LYNX | HTR-02-580303 | HNM TOTAL RECON LLC | HRS | 00841742112015 |
| LYNX | HTR-02-590264 | HNM TOTAL RECON LLC | HRS | 00841742112008 |
| LYNX | HTR-02-070838 | HNM TOTAL RECON LLC | HWC | 00841742111469 |
| ORTHOMED | OM 71-0243R | ORTHO-MED, INC. | HTY | B803710243R0 |