Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K212050
NGM WAVE PLIF Cage · NGMedical GmbH · decided 2021-12-01 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| BEE PLIF | T-Handle long | NGMedical GmbH | LXH | 04251631410850 |
| NGM WAVE | NGM WAVE Inserter Outer Tube | NGMedical GmbH | LXH | 04251631408659 |
| NGM WAVE PLIF Cage | 15 x 28 mm 0° | NGMedical GmbH | MAX | 04251631405849 |
| NGM WAVE | NGM WAVE Expansion Rod 28 mm | NGMedical GmbH | LXH | 04251631408680 |
| NGM WAVE PLIF Cage | 9 x 32 mm 6° | NGMedical GmbH | MAX | 04251631406068 |
| BEE PLIF | Distractor 10 x 30 mm 0° | NGMedical GmbH | LXH | 04251631410768 |
| NGM WAVE PLIF Cage | 15 x 32 mm 6° | NGMedical GmbH | MAX | 04251631406129 |
| BEE PLIF | Shaver 14 x 24 mm | NGMedical GmbH | LXH | 04251631414346 |
| BEE PLIF | Shaver 14 x 24 mm | NGMedical GmbH | LXH | 04251631410935 |
| NGM WAVE PLIF Cage | 10 x 32 mm 12° | NGMedical GmbH | MAX | 04251631406143 |
| BEE PLIF | Distractor 14 x 30 mm 0° | NGMedical GmbH | LXH | 04251631415954 |
| NGM WAVE PLIF Cage | 11 x 28 mm 12° | NGMedical GmbH | MAX | 04251631405948 |
| NGM WAVE PLIF Cage | 14 x 24 mm 6° | NGMedical GmbH | MAX | 04251631405696 |
| NGM WAVE PLIF Cage | 15 x 24 mm 0° | NGMedical GmbH | MAX | 04251631405634 |
| BEE PLIF | Distractor 7 x 30 mm 0° | NGMedical GmbH | LXH | 04251631412755 |
| BEE PLIF | Distractor 16 x 30 mm 0° | NGMedical GmbH | LXH | 04251631411284 |
| NGM WAVE | NGM WAVE Funnel | NGMedical GmbH | LXH | 04251631405559 |
| BEE PLIF | Shaver 14 x 24 mm | NGMedical GmbH | LXH | 04251631416050 |
| BEE PLIF | Shaver 16 x 24 mm | NGMedical GmbH | LXH | 04251631410959 |
| NGM WAVE PLIF Cage | 13 x 28 mm 12° | NGMedical GmbH | MAX | 04251631405962 |
| BEE PLIF | Wrench / Retractor | NGMedical GmbH | LXH | 04251631408697 |
| BEE PLIF | Shaver 12 x 24 mm | NGMedical GmbH | LXH | 04251631411369 |
| NGM WAVE PLIF Cage | 14 x 32 mm 6° | NGMedical GmbH | MAX | 04251631406112 |
| NGM WAVE PLIF Cage | 14 x 24 mm 0° | NGMedical GmbH | MAX | 04251631405627 |
| BEE PLIF | Shaver 12 x 24 mm | NGMedical GmbH | LXH | 04251631410911 |