Calix Spinal Implant System
11mm x 14mm x 12mm x 7°, Assembly, Lordotic, Calix
14manufacturers in China registered for this device type
192catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K170119 |
| Record published | 2019-10-11 |
| Record revised | 2021-06-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Height 5 to 20 mm; width 10 to 24 mm; length 11 to 36 mm; angle 5 to 12 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X034-0284PC-STR | Height 10 mm | In distribution |
| X003-0009 | Length 11 mm | In distribution |
| X034-0680 | Length 32 mm | In distribution |
| X034-0104 | Height 20 mm | In distribution |
| X034-0396PC-STR | Angle 5 ° | In distribution |
| X034-0335 | Width 24 mm | In distribution |
| X034-0103 | Length 28 mm | In distribution |
| X034-0395PC-STR | Angle 5 ° | In distribution |
| X034-0388PC-STR | Angle 5 ° | In distribution |
| X034-0247PC-STR | Height 11 mm | In distribution |
| X034-0135 | Width 24 mm | In distribution |
| X034-0174 | Length 22 mm | In distribution |
| X034-0218 | Length 22 mm | In distribution |
| X034-0244PC-STR | Height 14 mm | In distribution |
| X034-0173 | Length 22 mm | In distribution |
| X034-0105 | Length 28 mm | In distribution |
| X034-1422 | Length 32 mm | In distribution |
| X034-0121 | Height 14 mm | In distribution |
| X034-0677 | Width 10 mm | In distribution |
| X034-1649 | Length 32 mm | In distribution |
| X034-0172PC-STR | Height 7 mm | In distribution |
| X034-0675 | Length 32 mm | In distribution |
| X034-0181 | Width 10 mm | In distribution |
| X034-0391 | Width 10 mm | In distribution |
| X034-1429 | Height 15 mm | In distribution |
| X034-1648 | Width 10 mm | In distribution |
| X034-1425 | Height 11 mm | In distribution |
| X034-0287 | Height 13 mm | In distribution |
| X034-0215 | Height 10 mm | In distribution |
| X034-0211 | Length 22 mm | In distribution |
| X034-1424 | Width 10 mm | In distribution |
| X034-1430 | Length 32 mm | In distribution |
| X034-0214 | Length 22 mm | In distribution |
| X034-0253PC-STR | Height 16 mm | In distribution |
| X034-0120 | Length 28 mm | In distribution |
| X034-0288 | Width 10 mm | In distribution |
| X034-1641 | Angle 5 ° | In distribution |
| X034-0212 | Width 10 mm | In distribution |
| X034-0243PC-STR | Height 12 mm | In distribution |
| X034-0249 | Width 10 mm | In distribution |
| X034-1650 | Width 10 mm | In distribution |
| X003-0005 | Angle 7 ° | In distribution |
| X034-0393 | Width 10 mm | In distribution |
| X034-0283PC-STR | Height 9 mm | In distribution |
| X034-0282 | Width 10 mm | In distribution |
| X003-0012 | Width 14 mm | In distribution |
| X034-0132 | Length 28 mm | In distribution |
| X034-0676 | Height 12 mm | In distribution |
| X034-0387 | Length 26 mm | In distribution |
| X034-0289 | Width 10 mm | In distribution |
| X034-0133 | Width 24 mm | In distribution |
| X034-0178PC-STR | Height 13 mm | In distribution |
| X034-0247 | Length 26 mm | In distribution |
| X034-0112 | Height 16 mm | In distribution |
| X034-0324 | Length 36 mm | In distribution |
| X034-0333 | Width 24 mm | In distribution |
| X034-0033 | Height 16 mm | In distribution |
| X034-0326 | Length 36 mm | In distribution |
| X003-0011 | Length 11 mm | In distribution |
| X034-0330 | Angle 12 ° | In distribution |
| X034-0245PC-STR | Height 7 mm | In distribution |
| X034-0030 | Length 28 mm | In distribution |
| X034-0028 | Length 28 mm | In distribution |
| X034-1426 | Height 12 mm | In distribution |
| X034-0286 | Height 12 mm | In distribution |
| X034-0248PC-STR | Height 13 mm | In distribution |
| X034-0178 | Length 22 mm | In distribution |
| X034-0325 | Height 18 mm | In distribution |
| X034-1427 | Height 13 mm | In distribution |
| X034-0176PC-STR | Height 11 mm | In distribution |
| X034-0032 | Height 15 mm | In distribution |
| X034-0136 | Angle 12 ° | In distribution |
| X034-1643 | Length 32 mm | In distribution |
| X034-0031 | Width 12 mm | In distribution |
| X034-0289PC-STR | Height 15 mm | In distribution |
| X034-0282PC-STR | Height 8 mm | In distribution |
| X034-1420 | Width 10 mm | In distribution |
| X034-0281PC-STR | Height 7 mm | In distribution |
| X034-0389PC-STR | Angle 5 ° | In distribution |
| X034-0670 | Length 32 mm | In distribution |
| X034-0240 | Length 26 mm | In distribution |
| X034-0334 | Length 36 mm | In distribution |
| X034-0245 | Length 26 mm | In distribution |
| X034-0175PC-STR | Height 10 mm | In distribution |
| X034-0283 | Height 9 mm | In distribution |
| X034-0285 | Length 28 mm | In distribution |
| X034-0181PC-STR | Height 16 mm | In distribution |
| X034-0320 | Angle 8 ° | In distribution |
| X034-0026 | Width 12 mm | In distribution |
| X034-0394PC-STR | Angle 5 ° | In distribution |
| X034-0171PC-STR | Height 6 mm | In distribution |
| X034-0388 | Width 10 mm | In distribution |
| X034-0253 | Height 16 mm | In distribution |
| X034-0219 | Length 22 mm | In distribution |
| X003-0010 | Width 14 mm | In distribution |
| X034-0287PC-STR | Height 13 mm | In distribution |
| X034-0671 | Height 7 mm | In distribution |
| X034-1644 | Height 10 mm | In distribution |
| X034-0126 | Height 10 mm | In distribution |
| X034-0281 | Height 7 mm | In distribution |
| X034-1646 | Width 10 mm | In distribution |
| X034-0025 | Width 12 mm | In distribution |
| X034-0106 | Width 20 mm | In distribution |
| X034-0122 | Length 28 mm | In distribution |
| X034-0243 | Length 26 mm | In distribution |
| X034-0280PC-STR | Height 6 mm | In distribution |
| X034-0246 | Width 10 mm | In distribution |
| X034-0241PC-STR | Height 8 mm | In distribution |
| X034-0242 | Width 10 mm | In distribution |
| X034-0029 | Length 28 mm | In distribution |
| X034-0390PC-STR | Angle 5 ° | In distribution |
| X034-0221 | Angle 5 ° | In distribution |
| X034-0115 | Angle 12 ° | In distribution |
| X034-0176 | Width 10 mm | In distribution |
| X034-0288PC-STR | Height 14 mm | In distribution |
| X034-0111 | Height 14 mm | In distribution |
| X034-0100 | Height 12 mm | In distribution |
| X034-1647 | Height 13 mm | In distribution |
| X034-1423 | Length 32 mm | In distribution |
| X034-0131 | Height 14 mm | In distribution |
| X034-0321 | Width 24 mm | In distribution |
| X003-0007 | Height 7 mm | In distribution |
| X034-0286PC-STR | Height 12 mm | In distribution |
| X034-0280 | Length 28 mm | In distribution |
| X034-0124 | Height 20 mm | In distribution |
| X034-0336 | Length 36 mm | In distribution |
| X034-0180PC-STR | Height 15 mm | In distribution |
| X034-0217 | Length 22 mm | In distribution |
| X034-0332 | Width 24 mm | In distribution |
| X034-0392PC-STR | Angle 5 ° | In distribution |
| X034-0116 | Angle 12 ° | In distribution |
| X034-0679 | Height 15 mm | In distribution |
| X034-0114 | Width 20 mm | In distribution |
| X034-0395 | Angle 5 ° | In distribution |
| X034-0248 | Width 10 mm | In distribution |
| X034-0290 | Length 28 mm | In distribution |
| X003-0006 | Angle 7 ° | In distribution |
| X034-0177 | Width 10 mm | In distribution |
| X034-0240PC-STR | Height 6 mm | In distribution |
| X034-0396 | Width 10 mm | In distribution |
| X034-0134 | Angle 12 ° | In distribution |
| X034-0394 | Length 26 mm | In distribution |
| X034-0322 | Width 24 mm | In distribution |
| X034-0392 | Length 26 mm | In distribution |
| X034-0390 | Width 10 mm | In distribution |
| X034-0172 | Length 22 mm | In distribution |
| X034-1428 | Width 10 mm | In distribution |
| X034-0130 | Length 28 mm | In distribution |
| X003-0008 | Width 14 mm | In distribution |
| X034-0331 | Width 24 mm | In distribution |
| X034-0249PC-STR | Height 15 mm | In distribution |
| X034-0397 | Angle 5 ° | In distribution |
| X034-0323 | Width 24 mm | In distribution |
| X034-0113 | Height 18 mm | In distribution |
| X034-0125 | Width 24 mm | In distribution |
| X034-0179PC-STR | Height 14 mm | In distribution |
| X034-0678 | Length 32 mm | In distribution |
| X034-0242PC-STR | Height 10 mm | In distribution |
| X034-0180 | Height 15 mm | In distribution |
| X034-0290PC-STR | Height 16 mm | In distribution |
| X034-0101 | Height 14 mm | In distribution |
| X034-0389 | Angle 5 ° | In distribution |
| X034-0393PC-STR | Angle 5 ° | In distribution |
| X034-0674 | Length 32 mm | In distribution |
| X034-0123 | Height 18 mm | In distribution |
| X034-0241 | Height 8 mm | In distribution |
| X034-0397PC-STR | Angle 5 ° | In distribution |
| X034-0102 | Length 28 mm | In distribution |
| X034-1640 | Height 6 mm | In distribution |
| X034-1421 | Length 32 mm | In distribution |
| X034-0284 | Height 10 mm | In distribution |
| X034-0213 | Length 22 mm | In distribution |
| X034-0216 | Length 22 mm | In distribution |
| X034-0285PC-STR | Height 11 mm | In distribution |
| X034-1642 | Angle 5 ° | In distribution |
| X034-0110 | Width 20 mm | In distribution |
| X034-0171 | Height 6 mm | In distribution |
| X034-0244 | Width 10 mm | In distribution |
| X034-0179 | Length 22 mm | In distribution |
| X034-0246PC-STR | Height 9 mm | In distribution |
| X034-1645 | Length 32 mm | In distribution |
| X034-0672 | Height 8 mm | In distribution |
| X034-0175 | Length 22 mm | In distribution |
| X034-0387PC-STR | Angle 5 ° | In distribution |
| X034-0220 | Width 10 mm | In distribution |
| X034-0177PC-STR | Height 12 mm | In distribution |
| X034-0391PC-STR | Angle 5 ° | In distribution |
| X034-0174PC-STR | Height 9 mm | In distribution |
| X034-0027 | Height 10 mm | In distribution |
| X034-0173PC-STR | Height 8 mm | In distribution |
| X034-1640PC | Length 32 mm | In distribution |
| X034-0673 | Width 10 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Xtant Medical Holdings, Inc. | 510(k) number | 2018-12-19 | Class II | Labeling Change Control | This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration. | 632 units | 2021-04-01 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-05-17 | Class II | Component design/selection | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. | 195 units | 2019-04-04 |
| 2016-05-17 | Class II | Component design/selection | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. | 1186 units | 2019-04-04 |
| 2016-05-17 | Class II | Component design/selection | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. | 182 units | 2019-04-04 |
| 2016-05-17 | Class II | Component design/selection | The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space. | 1504 units | 2019-04-04 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.