Calix Spinal Implant System
15mm x 18mm x 12mm x 7°, Lordotic, Calix-C Plasma Coated Spacer
7manufacturers in China registered for this device type
202catalogue numbers in this listing
1recall
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 | Xtant Medical Holdings, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K171075 |
| Record published | 2015-11-27 |
| Record revised | 2021-06-03 (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 |
| Sizes | Width 10 to 24 mm; height 5 to 20 mm; length 11 to 36 mm; angle 5 to 12 °; depth 13 to 15 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X034-1423PC | Width 10 mm | In distribution |
| X034-1641PC | Angle 5 ° | In distribution |
| X034-0240PC | Width 10 mm | In distribution |
| X034-0106PC | Angle 8 ° | In distribution |
| X034-0282PC | Width 10 mm | In distribution |
| X034-0248PC | Width 10 mm | In distribution |
| X003-0631 | Depth 15 mm | In distribution |
| X003-0005PC | Height 5 mm | In distribution |
| X003-0221 | 16mm width x 6mm height x 7° Lordotic | In distribution |
| X034-0335PC | Width 24 mm | In distribution |
| X003-0634PC | Depth 15 mm | In distribution |
| X003-0632PC | 18mm width x 7mm height x 7° Lordotic | In distribution |
| X034-0680PC | Width 10 mm | In distribution |
| X034-0388PC | Width 10 mm | In distribution |
| X003-0655 | Depth 15 mm | In distribution |
| X034-1646PC | Height 12 mm | In distribution |
| X034-1643PC | Width 10 mm | In distribution |
| X003-0011PC | Width 14 mm | In distribution |
| X003-0616PC | 16mm width x 11mm height, Convex | In distribution |
| X034-1645PC | Height 11 mm | In distribution |
| X034-0245PC | Height 7 mm | In distribution |
| X034-0286PC | Length 28 mm | In distribution |
| X034-0180PC | Width 10 mm | In distribution |
| X034-0283PC | Length 28 mm | In distribution |
| X034-1644PC | Height 10 mm | In distribution |
| X003-0006PC | Length 11 mm | In distribution |
| X034-0177PC | Width 10 mm | In distribution |
| X034-0131PC | Angle 12 ° | In distribution |
| X003-0633 | 18mm width x 8mm height x 7° Lordotic | In distribution |
| X003-0012PC | Height 12 mm | In distribution |
| X034-0124PC | Angle 8 ° | In distribution |
| X034-1421PC | Length 32 mm | In distribution |
| X034-0176PC | Width 10 mm | In distribution |
| X034-0397PC | Height 16 mm | In distribution |
| X003-0010PC | Width 14 mm | In distribution |
| X034-0249PC | Length 26 mm | In distribution |
| X034-0281PC | Length 28 mm | In distribution |
| X003-0223 | 16mm width x 8mm height x 7° Lordotic | In distribution |
| X003-0655PC | 18mm width x 10mm height, Convex | In distribution |
| X003-0225 | Depth 13 mm | In distribution |
| X034-0125PC | Width 24 mm | In distribution |
| X003-0650 | Depth 15 mm | In distribution |
| X034-0321PC | Length 36 mm | In distribution |
| X034-0104PC | Length 28 mm | In distribution |
| X034-1430PC | Length 32 mm | In distribution |
| X003-0637PC | Depth 13 mm | In distribution |
| X003-0227PC | Depth 13 mm | In distribution |
| X034-0221PC | Width 10 mm | In distribution |
| X034-0101PC | Height 14 mm | In distribution |
| X034-1424PC | Height 10 mm | In distribution |
| X034-0395PC | Width 10 mm | In distribution |
| X034-0111PC | Angle 12 ° | In distribution |
| X034-0242PC | Height 10 mm | In distribution |
| X034-0100PC | Width 20 mm | In distribution |
| X003-0227 | 16mm width x 12mm height x 7° Lordotic | In distribution |
| X003-0635PC | 18mm width x 10mm height x 7° Lordotic | In distribution |
| X034-0284PC | Length 28 mm | In distribution |
| X034-0110PC | Length 28 mm | In distribution |
| X003-0615PC | 16mm width x 10mm height, Convex | In distribution |
| X003-0224PC | 16mm width x 9mm height x 7° Lordotic | In distribution |
| X034-0132PC | Width 24 mm | In distribution |
| X034-0243PC | Length 26 mm | In distribution |
| X003-0636 | 18mm width x 11mm height x 7° Lordotic | In distribution |
| X003-610PC | 16mm width x 5mm height, Convex | In distribution |
| X003-0652PC | 18mm width x 7mm height, Convex | In distribution |
| X034-0326PC | Length 36 mm | In distribution |
| X034-0215PC | Width 10 mm | In distribution |
| X034-0112PC | Length 28 mm | In distribution |
| X003-0223PC | 16mm width x 8mm height x 7° Lordotic | In distribution |
| X003-0633PC | Depth 15 mm | In distribution |
| X003-0611PC | Depth 13 mm | In distribution |
| X034-0212PC | Width 10 mm | In distribution |
| X034-0114PC | Angle 12 ° | In distribution |
| X003-0654 | 18mm width x 9mm height, Convex | In distribution |
| X003-0222PC | Depth 13 mm | In distribution |
| X034-1650PC | Angle 5 ° | In distribution |
| X003-0008PC | Angle 7 ° | In distribution |
| X034-0671PC | Height 7 mm | In distribution |
| X034-0289PC | Length 28 mm | In distribution |
| X003-0651 | 18mm width x 6mm height, Convex | In distribution |
| X034-0280PC | Length 28 mm | In distribution |
| X034-0387PC | Width 10 mm | In distribution |
| X003-0653 | 18mm width x 8mm height, Convex | In distribution |
| X003-0220 | 16mm width x 5mm height x 7° Lordotic | In distribution |
| X003-0612 | Depth 13 mm | In distribution |
| X034-0673PC | Length 32 mm | In distribution |
| X003-0610PC | Height 5 mm | In distribution |
| X003-0616 | Depth 13 mm | In distribution |
| X034-0217PC | Height 12 mm | In distribution |
| X034-0288PC | Length 28 mm | In distribution |
| X034-0323PC | Length 36 mm | In distribution |
| X003-0632 | Depth 15 mm | In distribution |
| X003-0221PC | 16mm width x 6mm height x 7° Lordotic | In distribution |
| X034-0181PC | Width 10 mm | In distribution |
| X034-0241PC | Length 26 mm | In distribution |
| X003-0657PC | 18mm width x 12mm height, Convex | In distribution |
| X034-1648PC | Angle 5 ° | In distribution |
| X034-0213PC | Width 10 mm | In distribution |
| X034-0105PC | Height 8 mm | In distribution |
| X034-0123PC | Width 24 mm | In distribution |
| X034-1647PC | Height 13 mm | In distribution |
| X034-0134PC | Width 24 mm | In distribution |
| X003-0657 | 18mm width x 12mm height, Convex | In distribution |
| X034-0331PC | Length 36 mm | In distribution |
| X034-0103PC | Angle 8 ° | In distribution |
| X003-0613PC | 16mm width x 8mm height, Convex | In distribution |
| X034-0290PC | Height 16 mm | In distribution |
| X003-0637 | Depth 13 mm | In distribution |
| X034-0133PC | Width 24 mm | In distribution |
| X034-0392PC | Width 10 mm | In distribution |
| X034-0172PC | Height 7 mm | In distribution |
| X003-0634 | 18mm width x 9mm height x 7° Lordotic | In distribution |
| X034-0220PC | Length 22 mm | In distribution |
| X003-0656 | 18mm width x 11mm height, Convex | In distribution |
| X034-0287PC | Width 10 mm | In distribution |
| X003-0652 | Depth 15 mm | In distribution |
| X003-0614 | Depth 13 mm | In distribution |
| X034-0121PC | Length 28 mm | In distribution |
| X034-0173PC | Height 8 mm | In distribution |
| X034-0672PC | Height 8 mm | In distribution |
| X034-0394PC | Width 10 mm | In distribution |
| X034-0178PC | Length 22 mm | In distribution |
| X003-0617 | Depth 13 mm | In distribution |
| X003-0636PC | 18mm width x 11mm height x 7° Lordotic | In distribution |
| X034-0219PC | Height 14 mm | In distribution |
| X034-0116PC | Height 10 mm | In distribution |
| X003-0615 | Depth 13 mm | In distribution |
| X034-0674PC | Width 10 mm | In distribution |
| X034-0218PC | Length 22 mm | In distribution |
| X003-0224 | Depth 13 mm | In distribution |
| X003-0631PC | Depth 15 mm | In distribution |
| X034-1427PC | Length 32 mm | In distribution |
| X034-0389PC | Angle 5 ° | In distribution |
| X034-0214PC | Width 10 mm | In distribution |
| X003-0617PC | 16mm width x 12mm height, Convex | In distribution |
| X034-1428PC | Length 32 mm | In distribution |
| X034-0126PC | Height 10 mm | In distribution |
| X003-0654PC | 18mm width x 9mm height, Convex | In distribution |
| X034-0171PC | Height 6 mm | In distribution |
| X034-0333PC | Length 36 mm | In distribution |
| X003-0635 | 18mm width x 10mm height x 7° Lordotic | In distribution |
| X034-0216PC | Width 10 mm | In distribution |
| X034-0679PC | Height 15 mm | In distribution |
| X034-0113PC | Angle 12 ° | In distribution |
| X034-0322PC | Height 12 mm | In distribution |
| X034-0253PC | Height 16 mm | In distribution |
| X034-0334PC | Length 36 mm | In distribution |
| X034-1642PC | Height 8 mm | In distribution |
| X034-0330PC | Width 24 mm | In distribution |
| X034-0285PC | Height 11 mm | In distribution |
| X003-0650PC | 18mm width x 5mm height, Convex | In distribution |
| X003-0007PC | Height 7 mm | In distribution |
| X003-0225PC | 16mm width x 10mm height x 7° Lordotic | In distribution |
| X034-0396PC | Angle 5 ° | In distribution |
| X034-1422PC | Length 32 mm | In distribution |
| X034-1426PC | Width 10 mm | In distribution |
| X034-0135PC | Length 28 mm | In distribution |
| X003-0220PC | 16mm width x 5mm height x 7° Lordotic | In distribution |
| X003-0611 | Depth 13 mm | In distribution |
| X034-0675PC | Width 10 mm | In distribution |
| X003-0653PC | 18mm width x 8mm height, Convex | In distribution |
| X034-0332PC | Height 12 mm | In distribution |
| X034-0115PC | Angle 12 ° | In distribution |
| X034-0393PC | Height 12 mm | In distribution |
| X034-1429PC | Height 15 mm | In distribution |
| X034-0247PC | Length 26 mm | In distribution |
| X034-0677PC | Length 32 mm | In distribution |
| X034-1649PC | Angle 5 ° | In distribution |
| X003-0226 | 16mm width x 11mm height x 7° Lordotic | In distribution |
| X034-0122PC | Height 16 mm | In distribution |
| X003-0630PC | 18mm width x 5mm height x 7° Lordotic | In distribution |
| X003-0614PC | 16mm width x 9mm height, Convex | In distribution |
| X003-0651PC | 18mm width x 6mm height, Convex | In distribution |
| X034-0670PC | Length 32 mm | In distribution |
| X034-0390PC | Angle 5 ° | In distribution |
| X003-0656PC | Depth 15 mm | In distribution |
| X034-0136PC | Width 24 mm | In distribution |
| X003-0222 | Depth 13 mm | In distribution |
| X003-0612PC | 16mm width x 7mm height, Convex | In distribution |
| X034-0211PC | Width 10 mm | In distribution |
| X034-0174PC | Width 10 mm | In distribution |
| X034-0336PC | Height 20 mm | In distribution |
| X034-1420PC | Width 10 mm | In distribution |
| X003-0630 | Depth 15 mm | In distribution |
| X003-0009PC | Length 11 mm | In distribution |
| X034-0676PC | Length 32 mm | In distribution |
| X034-1425PC | Length 32 mm | In distribution |
| X034-0324PC | Length 36 mm | In distribution |
| X034-0244PC | Width 10 mm | In distribution |
| X003-0610 | 16mm width x 5mm height, Convex | In distribution |
| X034-0179PC | Width 10 mm | In distribution |
| X034-0391PC | Angle 5 ° | In distribution |
| X034-0120PC | Width 24 mm | In distribution |
| X003-0613 | Depth 13 mm | In distribution |
| X034-0102PC | Angle 8 ° | In distribution |
| X034-0175PC | Length 22 mm | In distribution |
| X034-0678PC | Length 32 mm | In distribution |
| X003-0226PC | Depth 13 mm | In distribution |
| X034-0246PC | Height 9 mm | In distribution |
| X034-0325PC | Height 18 mm | In distribution |
| X034-0320PC | Height 8 mm | In distribution |
| X034-0130PC | Angle 12 ° | 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
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-09-30 | Class III | Labeling mix-ups | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. | 508 units | 2021-05-21 |
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.