CarboClear Navigated Instruments
510(k) K201251
CarboClear Navigated Instruments is a Class II device made by Carbofix Orthopedics Ltd, cleared under FDA 510(k) K201251 on 5 Aug 2020, 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 | NumberK201251 | Date5 Aug 2020 | StatusActive |
Official records
- FDA 510(k) database K201251
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLO
- FDA applicant
- CarboFix Orthopedics , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K201251
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 | |||
|---|---|---|---|---|
| CarboClear Pedicle Screw System Navigated Probe - Blunt, Straight | PPS922120N / Navigated Probe - Blunt, Straight | 07290110208400 | — | On the market |
| CarboClear Pedicle Screw System Navigated Probe - Pointed, Straight | PPS922650N / Navigated Probe - Pointed, Straight | 07290110208448 | — | On the market |
| CarboClear Pedicle Screw System Navigated Screwdriver | PPS922160N / Navigated Screwdriver | 07290110208417 | — | On the market |
| CarboClear Pedicle Screw System Navigated Tap 4.5mm | PPS922770N / Navigated Tap 4.5mm | 07290110208516 | Outer Diameter 4.5 mm | On the market |
| CarboClear Pedicle Screw System Navigated Tap 5.0mm | PPS922760N / Navigated Tap 5.0mm | 07290110208509 | Outer Diameter 5.0 mm | On the market |
| CarboClear Pedicle Screw System Navigated Tap 5.5mm | PPS922750N / Navigated Tap 5.5mm | 07290110208493 | Outer Diameter 5.5 mm | On the market |
| CarboClear Pedicle Screw System Navigated Tap 6.0mm | PPS922740N / Navigated Tap 6.0mm | 07290110208486 | Outer Diameter 6.0 mm | On the market |
| CarboClear Pedicle Screw System Navigated Tap 6.5mm | PPS922730N / Navigated Tap 6.5mm | 07290110208479 | Outer Diameter 6.5 mm | On the market |
| CarboClear Pedicle Screw System Navigated Tap 7.0mm | PPS922720N / Navigated Tap 7.0mm | 07290110208462 | Outer Diameter 7.0 mm | On the market |
| CarboClear Pedicle Screw System Navigated Tap 7.5mm | PPS922710N / Navigated Tap 7.5mm | 07290110208455 | Outer Diameter 7.5 mm | On the market |
Similar devices
Other devices filed under FDA product code OLO (Orthopedic Stereotaxic Instrument).
- VERTEX® Reconstruction System NAV2076 by MEDTRONIC SOFAMOR DANEK, INC.
- Innovasis Navigation Instruments by Innovasis, Inc.
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- Mako Total Knee Application by MAKO Surgical Corp.
- 6003-100-020 by Stryker Leibinger
- OrthAlign Plus 403468 by Orthalign, Inc.
- K2M Navigation Instruments by K2M, INC.
- NavLock™ 9734835 by Medtronic Navigation Inc.
- CD HORIZON® Spinal System RBT011003 by MEDTRONIC SOFAMOR DANEK, INC.