Katia™
Self-Drilling Cancellous Bone Screw - Variable Angle
7manufacturers in China registered for this device type
70catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Clariance, Inc., United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K130853 |
| Record published | 2015-10-22 |
| Record revised | 2025-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 10 to 110 mm; outer diameter 4 to 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60611417 | Length 17 mm | In distribution |
| 60614010 | Length 10 mm | In distribution |
| 60611415 | Length 15 mm | In distribution |
| 68620083 | Length 83.5 mm | In distribution |
| 60611517 | Length 17 mm | In distribution |
| 68620045 | Length 46 mm | In distribution |
| 60612417 | Length 17 mm | In distribution |
| 60612418 | Length 18 mm | In distribution |
| 68620065 | Length 66 mm | In distribution |
| 60612515 | Length 15 mm | In distribution |
| 68620073 | Length 73.5 mm | In distribution |
| 68620088 | Length 88.5 mm | In distribution |
| 60614017 | Length 17 mm | In distribution |
| 60611412 | Length 12 mm | In distribution |
| 60614016 | Length 16 mm | In distribution |
| 60612513 | Length 13 mm | In distribution |
| 68620047 | Length 48.5 mm | In distribution |
| 60612410 | Length 10 mm | In distribution |
| 68620040 | Length 41 mm | In distribution |
| 68620068 | Length 68.5 mm | In distribution |
| 68620025 | Length 26 mm | In distribution |
| 68620062 | Length 63.5 mm | In distribution |
| 68620058 | Length 58.5 mm | In distribution |
| 68620023 | Length 24 mm | In distribution |
| 68620019 | Length 20 mm | In distribution |
| 68620110 | Length 110 mm | In distribution |
| 68620043 | Length 43.5 mm | In distribution |
| 68620053 | Length 53 mm | In distribution |
| 60612517 | Length 17 mm | In distribution |
| 60614015 | Length 15 mm | In distribution |
| 68620050 | Length 50 mm | In distribution |
| 60614014 | Outer Diameter 4.0 mm | In distribution |
| 68620038 | Length 38.5 mm | In distribution |
| 68620080 | Length 81 mm | In distribution |
| 60614513 | Length 13 mm | In distribution |
| 68620056 | Length 56 mm | In distribution |
| 60612413 | Length 13 mm | In distribution |
| 60612411 | Length 11 mm | In distribution |
| 60611418 | Length 18 mm | In distribution |
| 68620090 | Length 91 mm | In distribution |
| 68620100 | Length 100 mm | In distribution |
| 68620075 | Length 76 mm | In distribution |
| 60612412 | Length 12 mm | In distribution |
| 68620032 | Length 33.5 mm | In distribution |
| 68620027 | Length 28.5 mm | In distribution |
| 60612414 | Length 14 mm | In distribution |
| 60614011 | Outer Diameter 4.0 mm | In distribution |
| 60611515 | Length 15 mm | In distribution |
| 60614517 | Length 17 mm | In distribution |
| 68620030 | Length 31 mm | In distribution |
| 60611414 | Length 14 mm | In distribution |
| 60614013 | Length 13 mm | In distribution |
| 60611410 | Length 10 mm | In distribution |
| 68620105 | Length 105 mm | In distribution |
| 60611416 | Outer Diameter 4.0 mm | In distribution |
| 68620070 | Length 71 mm | In distribution |
| 68620078 | Length 78.5 mm | In distribution |
| 60612416 | Length 16 mm | In distribution |
| 60611411 | Length 11 mm | In distribution |
| 60611513 | Length 13 mm | In distribution |
| 68620035 | Length 36 mm | In distribution |
| 68620095 | Length 95 mm | In distribution |
| 60614012 | Length 12 mm | In distribution |
| 60611413 | Length 13 mm | In distribution |
| 68620085 | Length 86 mm | In distribution |
| 60614515 | Length 15 mm | In distribution |
| 68620060 | Length 61 mm | In distribution |
| 60614018 | Length 18 mm | In distribution |
| 60612415 | Length 15 mm | In distribution |
| 68620021 | Length 22 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130853 | 2013-11-13 |
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.