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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K102795

SIGNATURE PLANNER; SIGNATURE GUIDES · Materialise NV · decided 2011-02-02 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Signature42-422557Materialise NVJWH MBH OIY OOGE314424225570
Signature42-422560Materialise NVJWH MBH OIY OOGE31442422560
Signature42-422577Materialise NVJWH MBH OIY OOGE314424225770
Signature42-422553Materialise NVJWH MBH OIY OOGE314424225530
Signature42-422571Materialise NVJWH MBH OIY OOGE314424225710
Signature42-422570Materialise NVJWH MBH OIY OOGE31442422570
Signature42-422555Materialise NVJWH MBH OIY OOGE314424225550
Signature42-422563Materialise NVJWH MBH OIY OOGE314424225630
Signature42-422578Materialise NVJWH MBH OIY OOGE314424225780
Signature42-422565Materialise NVJWH MBH OIY OOGE31442422565
Signature42-422562Materialise NVJWH MBH OIY OOGE314424225620
Signature™ Microplasty® Elite Instrumentation42-422502Biomet Orthopedics, LLCJWH MBH OIY OOG00887868507120
Signature42-422570Materialise NVJWH MBH OIY OOGE314424225700
Signature42-422558Materialise NVJWH MBH OIY OOGE314424225580
Signature42-422577Materialise NVJWH MBH OIY OOGE31442422577
Signature42-422566Materialise NVJWH MBH OIY OOGE31442422566
Signature42-422561Materialise NVJWH MBH OIY OOGE314424225610
Signature42-422553Materialise NVJWH MBH OIY OOGE31442422553
Signature42-422556Materialise NVJWH MBH OIY OOGE31442422556
Signature42-422576Materialise NVJWH MBH OIY OOGE31442422576
Signature42-422552Materialise NVJWH MBH OIY OOGE314424225520
Signature42-422558Materialise NVJWH MBH OIY OOGE31442422558
Signature42-422560Materialise NVJWH MBH OIY OOGE314424225600
Signature42-422563Materialise NVJWH MBH OIY OOGE31442422563
SIGNATURE42-422505Biomet Orthopedics, LLCJWH MBH OIY OOG00880304928510