CarboClear Posterior Cervical Screw System
Part of the CarboClear Posterior Cervical Screw System Instrumentation Set, serves as a guide and sleeve during the drilling and tapping procedure.
4manufacturers in China registered for this device type
80catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Manufacturer |
| 510(k) | K233989 |
| Record published | 2024-06-05 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 2 |
| Sizes | Outer diameter 2.3 to 5 mm; length 12 to 200 mm; lumen/inner diameter 4 to 4.5 mm |
| Distribution end date | 2024-11-28 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Rod Reducer | In distribution | ||
| Hybrid Screw | Length 22 mm | In distribution | |
| Drill Bit | Outer Diameter 4.0 mm | In distribution | |
| Hybrid Screw | Length 36 mm | In distribution | |
| Hybrid Screw | Length 30 mm | In distribution | |
| Hybrid Screw | Length 16 mm | In distribution | |
| Drill Bit | Outer Diameter 2.3 mm | In distribution | |
| Hybrid Screw | Length 28 mm | In distribution | |
| Hybrid Screw | Length 26 mm | In distribution | |
| Rod End Shaper | In distribution | ||
| Bone Tap | Outer Diameter 4 mm | In distribution | |
| Hybrid Screw | Length 40 mm | In distribution | |
| Hybrid Counter Torque | In distribution | ||
| Locker | In distribution | ||
| Extractor (Screw Removal) | Lumen/Inner Diameter 4.5 mm | In distribution | |
| Hybrid Screw | Length 35 mm | In distribution | |
| Drill Bit | Outer Diameter 3.5 mm | In distribution | |
| Sterilization Box | In distribution | ||
| Hybrid Screw | Length 40 mm | In distribution | |
| Hybrid Screw | Length 34 mm | In distribution | |
| Template – Rod Arc | Length 50 mm | In distribution | |
| Template – Rod | Length 80 mm | In distribution | |
| Cervical Screw | Outer Diameter 5.0 mm | In distribution | |
| Depth Gauge | In distribution | ||
| Bone Tap | Outer Diameter 4.5 mm | In distribution | |
| Distractor | In distribution | ||
| Hybrid Screw | Length 12 mm | In distribution | |
| Cervical Screw | Outer Diameter 5.0 mm | In distribution | |
| Template – Rod Arc | Length 80 mm | In distribution | |
| Hybrid Screw | Length 12 mm | In distribution | |
| Hybrid Screw | Length 14 mm | In distribution | |
| Hybrid Screw | Length 36 mm | In distribution | |
| Counter Torque | In distribution | ||
| Hybrid Screw | Length 32 mm | In distribution | |
| Holding Forceps | In distribution | ||
| Screw Block | In distribution | ||
| Hybrid Screw | Length 28 mm | In distribution | |
| Hybrid Screw | Length 14 mm | In distribution | |
| Cervical Bone Probe | In distribution | ||
| Cervical Awl | In distribution | ||
| Hybrid Screw | Length 20 mm | In distribution | |
| Cervical Screw | Outer Diameter 5.0 mm | In distribution | |
| Bone Surface Reamer | In distribution | ||
| Hybrid Screw | Length 24 mm | In distribution | |
| Bone Tap | Outer Diameter 5.0 mm | In distribution | |
| Torque Limiter 0.8Nm | In distribution | ||
| Adjustable Drill Guide | In distribution | ||
| Tap Sleeve | In distribution | ||
| Cervical Feeler | In distribution | ||
| Template – Rod | Length 50 mm | In distribution | |
| Set Screw | 2 | In distribution | |
| Hybrid Screw | Length 38 mm | In distribution | |
| Shaped Rod – Type A | Length 200 mm | In distribution | |
| Hybrid Screw | Length 24 mm | In distribution | |
| Hybrid Screw | Length 16 mm | In distribution | |
| Extractor (Screw Removal) | Lumen/Inner Diameter 4.0 mm | In distribution | |
| Hybrid Screw | Length 34 mm | In distribution | |
| Hybrid Screw | Length 32 mm | In distribution | |
| Hybrid Angle Adjuster | In distribution | ||
| Tulip Adjuster | In distribution | ||
| Hybrid Screw | Length 30 mm | In distribution | |
| Shaped Rod – Type B | Length 200 mm | In distribution | |
| Hybrid Screw | Length 18 mm | In distribution | |
| Rod Reducer Handle | In distribution | ||
| Cervical Screwdriver | In distribution | ||
| Starter | In distribution | ||
| Hybrid Screw | Length 20 mm | In distribution | |
| Hybrid Screw | Length 40 mm | In distribution | |
| Hybrid Screw | Length 22 mm | In distribution | |
| Rod Pusher | In distribution | ||
| Hybrid Screw | Length 26 mm | In distribution | |
| Hybrid Screw | Length 25 mm | In distribution | |
| Hybrid Screw | Length 30 mm | In distribution | |
| Torque Limiter 2.5Nm | In distribution | ||
| Compressor | In distribution | ||
| Hybrid Screw | Length 20 mm | In distribution | |
| Hybrid Screw | Length 18 mm | In distribution | |
| Cutting Set | In distribution | ||
| Hybrid Screw | Length 38 mm | In distribution | |
| Saw | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Yukon OCT Spinal System | VB Spine LLC | 451 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254045 | 2026-03-16 |
| K233989 | 2024-03-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.