Capstone Control PTC Spinal System
Spacer 5031322 Control PTC 24 DEG 13X22
14manufacturers in China registered for this device type
94catalogue numbers in this listing
18510(k) clearances naming this product 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 | Medtronic Sofamor Danek, 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 |
| 510(k) | K171107 |
| Record published | 2018-09-01 |
| Record revised | 2023-09-08 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Angle 0 to 24 °; length 22 to 32 mm; height 8 to 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5001222 | Angle 6.0 ° | In distribution |
| 5031322 | Height 13.0 mm | In distribution |
| 4991132 | Length 32.0 mm | In distribution |
| 5011122 | Height 11.0 mm | In distribution |
| 5021322 | Angle 18.0 ° | In distribution |
| 5031727 | Angle 24.0 ° | In distribution |
| 5001127 | Angle 6.0 ° | In distribution |
| 5001027 | Height 10.0 mm | In distribution |
| 5001722 | Angle 6.0 ° | In distribution |
| 5021727 | Length 27.0 mm | In distribution |
| 5021722 | Angle 18.0 ° | In distribution |
| 5011827 | Length 27.0 mm | In distribution |
| 4991732 | Angle 0.0 ° | In distribution |
| 5011222 | Angle 12.0 ° | In distribution |
| 4990927 | Length 27.0 mm | In distribution |
| 5001632 | Height 16.0 mm | In distribution |
| 5031627 | Length 27.0 mm | In distribution |
| 5021422 | Height 14.0 mm | In distribution |
| 4991432 | Height 14.0 mm | In distribution |
| 5001627 | Angle 6.0 ° | In distribution |
| 5011422 | Angle 12.0 ° | In distribution |
| 5031827 | Length 27.0 mm | In distribution |
| 5011627 | Height 16.0 mm | In distribution |
| 4991722 | Length 22.0 mm | In distribution |
| 5001332 | Length 32.0 mm | In distribution |
| 4991322 | Angle 0.0 ° | In distribution |
| 5001432 | Angle 6.0 ° | In distribution |
| 4991027 | Length 27.0 mm | In distribution |
| 4991227 | Height 12.0 mm | In distribution |
| 4991622 | Height 16.0 mm | In distribution |
| 5001227 | Height 12.0 mm | In distribution |
| 4991032 | Angle 0.0 ° | In distribution |
| 4991822 | Height 18.0 mm | In distribution |
| 4990922 | Height 9.0 mm | In distribution |
| 4991427 | Angle 0.0 ° | In distribution |
| 4991232 | Length 32.0 mm | In distribution |
| 5011427 | Height 14.0 mm | In distribution |
| 5031522 | Length 22.0 mm | In distribution |
| 4991422 | Angle 0.0 ° | In distribution |
| 5021627 | Height 16.0 mm | In distribution |
| 4991522 | Length 22.0 mm | In distribution |
| 4991532 | Height 15.0 mm | In distribution |
| 5001322 | Length 22.0 mm | In distribution |
| 5001822 | Angle 6.0 ° | In distribution |
| 4991022 | Angle 0.0 ° | In distribution |
| 5001622 | Angle 6.0 ° | In distribution |
| 5001532 | Height 15.0 mm | In distribution |
| 5001327 | Height 13.0 mm | In distribution |
| 4991727 | Length 27.0 mm | In distribution |
| 5031422 | Length 22.0 mm | In distribution |
| 5001427 | Length 27.0 mm | In distribution |
| 5021527 | Length 27.0 mm | In distribution |
| 4990827 | Angle 0.0 ° | In distribution |
| 5031722 | Length 22.0 mm | In distribution |
| 5011822 | Angle 12.0 ° | In distribution |
| 5021622 | Length 22.0 mm | In distribution |
| 5011227 | Height 12.0 mm | In distribution |
| 5011522 | Length 22.0 mm | In distribution |
| 4991527 | Length 27.0 mm | In distribution |
| 5001827 | Length 27.0 mm | In distribution |
| 5001527 | Length 27.0 mm | In distribution |
| 5001522 | Angle 6.0 ° | In distribution |
| 5001422 | Angle 6.0 ° | In distribution |
| 5031622 | Angle 24.0 ° | In distribution |
| 5011727 | Angle 12.0 ° | In distribution |
| 5001022 | Angle 6.0 ° | In distribution |
| 4991222 | Angle 0.0 ° | In distribution |
| 4991632 | Angle 0.0 ° | In distribution |
| 4991122 | Height 11.0 mm | In distribution |
| 4991827 | Length 27.0 mm | In distribution |
| 5001732 | Length 32.0 mm | In distribution |
| 5031527 | Angle 24.0 ° | In distribution |
| 5001232 | Height 12.0 mm | In distribution |
| 5001132 | Length 32.0 mm | In distribution |
| 5001727 | Length 27.0 mm | In distribution |
| 5021522 | Angle 18.0 ° | In distribution |
| 4990822 | Length 22.0 mm | In distribution |
| 5011327 | Length 27.0 mm | In distribution |
| 5011022 | Length 22.0 mm | In distribution |
| 5031822 | Angle 24.0 ° | In distribution |
| 4991332 | Angle 0.0 ° | In distribution |
| 5011322 | Angle 12.0 ° | In distribution |
| 4991327 | Height 13.0 mm | In distribution |
| 4991127 | Length 27.0 mm | In distribution |
| 5011527 | Length 27.0 mm | In distribution |
| 5021427 | Angle 18.0 ° | In distribution |
| 5001122 | Height 11.0 mm | In distribution |
| 4991832 | Height 18.0 mm | In distribution |
| 5011622 | Angle 12.0 ° | In distribution |
| 5021827 | Height 18.0 mm | In distribution |
| 5001832 | Angle 6.0 ° | In distribution |
| 5011722 | Angle 12.0 ° | In distribution |
| 5021822 | Height 18.0 mm | In distribution |
| 4991627 | Angle 0.0 ° | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201267 | 2020-08-26 |
| K172199 | 2017-09-19 |
| K171031 | 2017-07-06 |
| K171468 | 2017-06-13 |
| K132897 | 2013-12-11 |
| K133216 | 2013-11-22 |
| K132700 | 2013-09-26 |
| K123027 | 2013-07-25 |
| K122037 | 2013-03-22 |
| K122591 | 2012-09-18 |
| K111525 | 2011-08-24 |
| K103731 | 2011-07-18 |
| K100175 | 2010-06-02 |
| K094025 | 2010-04-26 |
| K090353 | 2009-09-29 |
| K083026 | 2008-12-29 |
| K082342 | 2008-09-12 |
| K080083 | 2008-04-10 |
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.