Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ONPOINT SPHERZ PASSIVE MARKER-12 PACK | DS0211201 | Izi Medical Products, LLC | HAW | 00815212026843 |
| nView 639 Long Micro-Reference Clip | 639 | Izi Medical Products, LLC | HAW | 00815212026744 |
| Snap On Spherz | 2010-130 | Izi Medical Products, LLC | HAW | 00815212021459 |
| Quick Spherz | 2021-130 | Izi Medical Products, LLC | HAW | 00815212021633 |
| Bone Filler Kit | G80005 | Izi Medical Products, LLC | NDN | 00815212021404 |
| Snap On Spherz | 2010-01 | Izi Medical Products, LLC | HAW | 00815212021343 |
| Snap On Spherz | PM8108 | Izi Medical Products, LLC | HAW | 00815212020698 |
| ORTHO-KEY | 2010-05-ORTHO | Izi Medical Products, LLC | HAW | 00815212026737 |
| Threaded Spherz | TS2003 | Izi Medical Products, LLC | HAW | 00815212020438 |
| Snap On Spherz | PM1010 | Izi Medical Products, LLC | HAW | 00815212020537 |
| Snap On Spherz | 2010-40 | Izi Medical Products, LLC | HAW | 00815212022937 |
| Spinoplasty Kit | G80006 | Izi Medical Products, LLC | NDN | 00815212021374 |
| Snap On Spherz | PM8060 | Izi Medical Products, LLC | HAW | 00815212020681 |
| Snap On Spherz | PM8003 | Izi Medical Products, LLC | HAW | 00815212020568 |
| nView 603 Extra Reflective Marker | 603 | Izi Medical Products, LLC | HAW | 00815212026706 |
| Snap On Spherz | 2010-100 | Izi Medical Products, LLC | HAW | 00815212021435 |
| Snap On Spherz | PM8030 | Izi Medical Products, LLC | HAW | 00815212020650 |
| Snap On Spherz | PM8012 | Izi Medical Products, LLC | HAW | 00815212020612 |
| Quick Spherz | QS7003 | Izi Medical Products, LLC | HAW | 00815212020490 |
| Snap On Spherz | 2010-04 | Izi Medical Products, LLC | HAW | 00815212021411 |
| Snap On Spherz | PM1010-I | Izi Medical Products, LLC | HAW | 00815212020544 |
| SPHERZ: ILUMARK SNAP EASYFIT 2010-05 | 2010-05 | Izi Medical Products, LLC | HAW | 00815212021428 |
| Snap On Spherz | PM8035 | Izi Medical Products, LLC | HAW | 00815212020667 |
| Quick Spherz | QS7004 | Izi Medical Products, LLC | HAW | 00815212020506 |
| Snap On Spherz | 2010-160 | Izi Medical Products, LLC | HAW | 00815212021466 |