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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)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Key Surgical K-Wires and Steinmann PinsKI-71-124KEY SURGICAL, INC.HRS HTY HWC00849771012436
HNM MEDICALHKW-18-090011HNM STAINLESS, LLC.HTY00842962105986
LYNXHTR-02-510214HNM TOTAL RECON LLCHRS00841742111803
(unnamed)K-Wires and Steinmann PinsKEY SURGICAL, INC.HRS HTY HWC10849771050268
(unnamed)K-Wires and Steinmann PinKEY SURGICAL, INC.HRS HTY HWC10849771049965
(unnamed)K-Wires and Steinmann PinsKEY SURGICAL, INC.HRS HTY HWC10849771049941
Key Surgical K-Wires and Steinmann PinsKI-71-768KEY SURGICAL, INC.HTY00849771015598
Key Surgical K-Wires and Steinmann PinsKI-71-633KEY SURGICAL, INC.HTY00849771015000
Key Surgical K-Wires and Steinmann PinsKI-71-208KEY SURGICAL, INC.HRS HTY HWC00849771012764
Key Surgical K-Wires and Steinmann PinsKI-71-121KEY SURGICAL, INC.HRS HTY HWC00849771012405
Key Surgical K-Wires and Steinmann PinsKI-71-030KEY SURGICAL, INC.HRS HTY HWC00849771012139
POLARISHTR-02-031026HNM TOTAL RECON LLCHWC00841742113500
LYNXHTR-02-800885HNM TOTAL RECON LLCHRS00841742113067
LYNXHTR-02-110307HNM TOTAL RECON LLCHRS00841742112718
LYNXHTR-02-070912HNM TOTAL RECON LLCHRS00841742112473
LYNXHTR-02-070412HNM TOTAL RECON LLCHWC00841742111322
(unnamed)K-Wires and Steinmann PinKEY SURGICAL, INC.HRS HTY HWC10849771049972
(unnamed)K-Wires and Steinmann PinKEY SURGICAL, INC.HRS HTY HWC10849771049859
Key Surgical K-Wires and Steinmann PinsKI-71-762KEY SURGICAL, INC.HTY00849771015536
HNM MEDICALHKW-12-040014HNM STAINLESS, LLC.HTY00842962105450
LYNXHTR-02-810555HNM TOTAL RECON LLCHRS00841742113135
LYNXHTR-02-580303HNM TOTAL RECON LLCHRS00841742112015
LYNXHTR-02-590264HNM TOTAL RECON LLCHRS00841742112008
LYNXHTR-02-070838HNM TOTAL RECON LLCHWC00841742111469
ORTHOMEDOM 71-0243RORTHO-MED, INC.HTYB803710243R0