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)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Signature | 42-422557 | Materialise NV | JWH MBH OIY OOG | E314424225570 |
| Signature | 42-422560 | Materialise NV | JWH MBH OIY OOG | E31442422560 |
| Signature | 42-422577 | Materialise NV | JWH MBH OIY OOG | E314424225770 |
| Signature | 42-422553 | Materialise NV | JWH MBH OIY OOG | E314424225530 |
| Signature | 42-422571 | Materialise NV | JWH MBH OIY OOG | E314424225710 |
| Signature | 42-422570 | Materialise NV | JWH MBH OIY OOG | E31442422570 |
| Signature | 42-422555 | Materialise NV | JWH MBH OIY OOG | E314424225550 |
| Signature | 42-422563 | Materialise NV | JWH MBH OIY OOG | E314424225630 |
| Signature | 42-422578 | Materialise NV | JWH MBH OIY OOG | E314424225780 |
| Signature | 42-422565 | Materialise NV | JWH MBH OIY OOG | E31442422565 |
| Signature | 42-422562 | Materialise NV | JWH MBH OIY OOG | E314424225620 |
| Signature™ Microplasty® Elite Instrumentation | 42-422502 | Biomet Orthopedics, LLC | JWH MBH OIY OOG | 00887868507120 |
| Signature | 42-422570 | Materialise NV | JWH MBH OIY OOG | E314424225700 |
| Signature | 42-422558 | Materialise NV | JWH MBH OIY OOG | E314424225580 |
| Signature | 42-422577 | Materialise NV | JWH MBH OIY OOG | E31442422577 |
| Signature | 42-422566 | Materialise NV | JWH MBH OIY OOG | E31442422566 |
| Signature | 42-422561 | Materialise NV | JWH MBH OIY OOG | E314424225610 |
| Signature | 42-422553 | Materialise NV | JWH MBH OIY OOG | E31442422553 |
| Signature | 42-422556 | Materialise NV | JWH MBH OIY OOG | E31442422556 |
| Signature | 42-422576 | Materialise NV | JWH MBH OIY OOG | E31442422576 |
| Signature | 42-422552 | Materialise NV | JWH MBH OIY OOG | E314424225520 |
| Signature | 42-422558 | Materialise NV | JWH MBH OIY OOG | E31442422558 |
| Signature | 42-422560 | Materialise NV | JWH MBH OIY OOG | E314424225600 |
| Signature | 42-422563 | Materialise NV | JWH MBH OIY OOG | E31442422563 |
| SIGNATURE | 42-422505 | Biomet Orthopedics, LLC | JWH MBH OIY OOG | 00880304928510 |