Facet Screw System
510(k) K101284
Facet Screw System is a device classified as Unclassified made by Nuvasive, Inc., cleared under FDA 510(k) K101284 on 15 Jul 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101284 | Date15 Jul 2010 | StatusActive |
Official records
- FDA 510(k) database K101284
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MRW
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K101284
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Radian 5524520 | 5524520 | 00887517251091 | — | On the market |
| Radian 5544525 | 5544525 | 00887517255365 | — | On the market |
| Radian 5544530 | 5544530 | 00887517255372 | — | On the market |
| Radian 5544535 | 5544535 | 00887517255389 | — | On the market |
| Radian 5544540 | 5544540 | 00887517255396 | — | On the market |
| Radian 5544545 | 5544545 | 00887517255709 | — | On the market |
| Radian 5544550 | 5544550 | 00887517255716 | — | On the market |
| Radian 5544555 | 5544555 | 00887517255723 | — | On the market |
| Radian 5554525 | 5554525 | 00887517255747 | — | On the market |
| Radian 5554530 | 5554530 | 00887517255754 | — | On the market |
| Radian 5554535 | 5554535 | 00887517255761 | — | On the market |
| Radian 5554540 | 5554540 | 00887517255778 | — | On the market |
| Radian 5554545 | 5554545 | 00887517255785 | — | On the market |
| Radian 5554550 | 5554550 | 00887517255792 | — | On the market |
| Radian 5554555 | 5554555 | 00887517256102 | — | On the market |
| Radian 5565225 | 5565225 | 00887517257109 | — | On the market |
| Radian 5565230 | 5565230 | 00887517257116 | — | On the market |
| Radian 5565235 | 5565235 | 00887517257123 | — | On the market |
| Radian 5565240 | 5565240 | 00887517257130 | — | On the market |
| Radian 5565245 | 5565245 | 00887517257147 | — | On the market |
| Radian 5565250 | 5565250 | 00887517257154 | — | On the market |
| Radian 5565255 | 5565255 | 00887517257161 | — | On the market |
| Radian 5575225 | 5575225 | 00887517259325 | — | On the market |
| Radian 5575230 | 5575230 | 00887517259332 | — | On the market |
| Radian 5575235 | 5575235 | 00887517259349 | — | On the market |
| Radian 5575240 | 5575240 | 00887517259356 | — | On the market |
| Radian 5575245 | 5575245 | 00887517259363 | — | On the market |
| Radian 5575250 | 5575250 | 00887517259370 | — | On the market |
| Radian 5575255 | 5575255 | 00887517259387 | — | On the market |
Similar devices
Other devices filed under FDA product code MRW (System, Facet Screw Spinal Device).
- DiversiVy™ Facet Screw System by VY SPINE LLC
- LIFE SPINE FACET SCREW SPINAL SYSTEM by Life Spine, Inc.
- DISCOVERY FACET SCREW FIXATION SYSTEM by Depuyacromed
- CORUS-LX Implant by Providence Medical Technology
- PMT Expandable Cage (PMT EXP) by Providence Medical Technology
- Proficient (TM) Facet Screw Spine System by Spine Wave, Inc.
- Ion-L by SURGENTEC LLC
- Ion-C by SURGENTEC LLC
- ZYGAFIX SPINAL FACET SCREW SYSTEM by X-Spine Systems, Inc.
- KYPHON ANCHOR FACET SCREW SYSTEM by Medtronic Spine, LLC