Novel
Novel Lumbar Spacer, 16 mm Medium, 12deg Lordotic, Titanium
14manufacturers in China registered for this device type
238catalogue numbers in this listing
21510(k) clearances naming this product code
3recalls 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 | Alphatec Spine, 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, Exporter |
| 510(k) | K080699 |
| Record published | 2015-08-31 |
| Record revised | 2023-04-07 (version 6) |
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 | Length 20 to 36 mm; height 7 to 20 mm; width 8 to 36 mm; angle 5 to 12 ° |
| Distribution end date | 2023-04-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 64405-414 | Angle 12 ° | In distribution |
| 64612-007 | Width 10 mm | In distribution |
| 64614-015 | Length 24 mm | In distribution |
| 64677-115 | Length 28 mm | In distribution |
| 64195-108 | Angle 5 ° | In distribution |
| 64401-412 | Angle 12 ° | In distribution |
| 64635-111 | Width 10 mm | In distribution |
| 64616-117 | Length 28 mm | In distribution |
| 64637-015 | Width 10 mm | In distribution |
| 64616-010 | Height 10 mm | In distribution |
| 64923-414 | Height 14 mm | In distribution |
| 64618-112 | Angle 5 ° | In distribution |
| 64193-010 | Height 10 mm | In distribution |
| 64632-107 | Angle 5 ° | In distribution |
| 64637-115 | Width 10 mm | In distribution |
| 64403-416 | Height 16 mm | In distribution |
| 64677-114 | Length 28 mm | In distribution |
| 64405-412 | Angle 12 ° | In distribution |
| 64401-214 | Height 14 mm | In distribution |
| 64636-110 | Angle 5 ° | In distribution |
| 64195-008 | Width 10 mm | In distribution |
| 64618-117 | Length 30 mm | In distribution |
| 64405-216 | Height 16 mm | In distribution |
| 64637-108 | Width 10 mm | In distribution |
| 64195-010 | Height 10 mm | In distribution |
| 64925-208 | Width 32 mm | In distribution |
| 64637-117 | Angle 5 ° | In distribution |
| 64401-208 | Width 23 mm | In distribution |
| 64401-414 | Angle 12 ° | In distribution |
| 64401-218 | Height 18 mm | In distribution |
| 64193-110 | Length 20 mm | In distribution |
| 64191-010 | Length 20 mm | In distribution |
| 64634-02 | In distribution | |
| 64923-418 | Width 26 mm | In distribution |
| 64403-210 | Width 26 mm | In distribution |
| 64677-113 | Height 13 mm | In distribution |
| 64675-115 | Height 15 mm | In distribution |
| 64675-113 | Angle 5 ° | In distribution |
| 64635-010 | Length 24 mm | In distribution |
| 64632-112 | Length 24 mm | In distribution |
| 64192-008 | Width 8 mm | In distribution |
| 64637-010 | Width 10 mm | In distribution |
| 64618-111 | Height 11 mm | In distribution |
| 64618-015 | Height 15 mm | In distribution |
| 64925-210 | Angle 7 ° | In distribution |
| 64635-110 | Length 24 mm | In distribution |
| 64403-418 | Length 32 mm | In distribution |
| 64637-110 | Length 30 mm | In distribution |
| 64401-210 | Width 23 mm | In distribution |
| 64612-110 | Angle 5 ° | In distribution |
| 64925-218 | Width 32 mm | In distribution |
| 64616-007 | Width 10 mm | In distribution |
| 64191-110 | Length 20 mm | In distribution |
| 64612-011 | Width 10 mm | In distribution |
| 64614-115 | Angle 5 ° | In distribution |
| 64616-109 | Width 10 mm | In distribution |
| 64612-107 | Length 22 mm | In distribution |
| 64636-116 | Width 10 mm | In distribution |
| 64636-113 | Length 28 mm | In distribution |
| 64923-408 | Width 26 mm | In distribution |
| 64405-420 | Width 30 mm | In distribution |
| 64195-012 | Height 12 mm | In distribution |
| 64637-012 | Length 30 mm | In distribution |
| 64616-116 | Width 10 mm | In distribution |
| 64637-013 | Length 30 mm | In distribution |
| 64637-008 | Height 8 mm | In distribution |
| 64636-016 | Height 16 mm | In distribution |
| 64637-016 | Length 30 mm | In distribution |
| 64193-108 | Height 8 mm | In distribution |
| 64614-113 | Height 13 mm | In distribution |
| 64636-111 | Width 10 mm | In distribution |
| 64195-014 | Length 25 mm | In distribution |
| 64405-218 | Length 36 mm | In distribution |
| 64925-418 | Length 26 mm | In distribution |
| 64614-012 | Height 12 mm | In distribution |
| 64632-108 | Width 10 mm | In distribution |
| 64614-111 | Width 10 mm | In distribution |
| 64612-109 | Width 10 mm | In distribution |
| 64632-110 | Angle 5 ° | In distribution |
| 64636-017 | Length 28 mm | In distribution |
| 64405-220 | Length 36 mm | In distribution |
| 64616-008 | Width 10 mm | In distribution |
| 64636-012 | Height 12 mm | In distribution |
| 64195-112 | Width 10 mm | In distribution |
| 64618-012 | Height 12 mm | In distribution |
| 64637-113 | Width 10 mm | In distribution |
| 64401-216 | Height 16 mm | In distribution |
| 64632-109 | Length 24 mm | In distribution |
| 64637-111 | Length 30 mm | In distribution |
| 64191-008 | Height 8 mm | In distribution |
| 64403-420 | Angle 12 ° | In distribution |
| 64403-216 | Width 26 mm | In distribution |
| 64403-412 | Width 26 mm | In distribution |
| 64636-015 | Height 15 mm | In distribution |
| 64192-110 | Width 8 mm | In distribution |
| 64618-008 | Length 30 mm | In distribution |
| 64927-212 | Angle 7 ° | In distribution |
| 64637-107 | Angle 5 ° | In distribution |
| 64403-220 | Height 20 mm | In distribution |
| 64636-112 | Angle 5 ° | In distribution |
| 64403-214 | Angle 7 ° | In distribution |
| 64637-114 | Angle 5 ° | In distribution |
| 64635-109 | Angle 5 ° | In distribution |
| 64637-109 | Width 10 mm | In distribution |
| 64925-412 | Angle 12 ° | In distribution |
| 64635-112 | Length 24 mm | In distribution |
| 64193-012 | Height 12 mm | In distribution |
| 64614-014 | Width 10 mm | In distribution |
| 64635-108 | Length 24 mm | In distribution |
| 64927-210 | Height 10 mm | In distribution |
| 64401-410 | Width 23 mm | In distribution |
| 64636-109 | Angle 5 ° | In distribution |
| 64632-111 | Angle 5 ° | In distribution |
| 64195-114 | Height 14 mm | In distribution |
| 64193-014 | Width 10 mm | In distribution |
| 64403-218 | Angle 7 ° | In distribution |
| 64923-416 | Height 16 mm | In distribution |
| 64637-017 | Length 30 mm | In distribution |
| 64920 | In distribution | |
| 64632-113 | Angle 5 ° | In distribution |
| 64636-009 | Height 9 mm | In distribution |
| 64616-107 | Height 7 mm | In distribution |
| 64635-107 | Angle 5 ° | In distribution |
| 64405-416 | Length 36 mm | In distribution |
| 64927-414 | Length 30 mm | In distribution |
| 64637-009 | Width 10 mm | In distribution |
| 64635-012 | Height 12 mm | In distribution |
| 64637-116 | Angle 5 ° | In distribution |
| 64636-008 | Height 8 mm | In distribution |
| 64401-420 | Length 26 mm | In distribution |
| 64636-114 | Length 28 mm | In distribution |
| 64635-007 | Length 24 mm | In distribution |
| 64636-013 | Length 28 mm | In distribution |
| 64923-210 | Angle 7 ° | In distribution |
| 64632-115 | Height 15 mm | In distribution |
| 64637-007 | Length 30 mm | In distribution |
| 64405-214 | Angle 7 ° | In distribution |
| 64636-007 | Width 10 mm | In distribution |
| 64401-212 | Angle 7 ° | In distribution |
| 64635-114 | Length 24 mm | In distribution |
| 64618-009 | Width 10 mm | In distribution |
| 64923-412 | Height 12 mm | In distribution |
| 64195-110 | Height 10 mm | In distribution |
| 64401-418 | Angle 12 ° | In distribution |
| 64191-108 | Width 8 mm | In distribution |
| 64637-011 | Width 10 mm | In distribution |
| 64193-008 | Length 20 mm | In distribution |
| 64636-115 | Length 28 mm | In distribution |
| 64637-112 | Height 12 mm | In distribution |
| 64612-113 | Angle 5 ° | In distribution |
| 64634-01 | In distribution | |
| 64193-114 | Angle 5 ° | In distribution |
| 64923-208 | Width 26 mm | In distribution |
| 64614-009 | Height 9 mm | In distribution |
| 64925-216 | Angle 7 ° | In distribution |
| 64403-410 | Angle 12 ° | In distribution |
| 64927-416 | Height 16 mm | In distribution |
| 64637-014 | Width 10 mm | In distribution |
| 64636-011 | Length 28 mm | In distribution |
| 64616-015 | Height 15 mm | In distribution |
| 64636-108 | Angle 5 ° | In distribution |
| CI-10331 | In distribution | |
| 64405-418 | Angle 12 ° | In distribution |
| 64635-113 | Length 24 mm | In distribution |
| 64616-017 | Height 17 mm | In distribution |
| 64618-114 | Height 14 mm | In distribution |
| 64403-414 | Height 14 mm | In distribution |
| 64636-014 | Width 10 mm | In distribution |
| 64616-115 | Height 15 mm | In distribution |
| 64632-114 | Height 14 mm | In distribution |
| 64636-107 | Height 7 mm | In distribution |
| 64612-010 | Length 22 mm | In distribution |
| 64618-107 | Width 10 mm | In distribution |
| 64403-212 | Height 12 mm | In distribution |
| 64923-410 | Angle 12 ° | In distribution |
| 64405-212 | Angle 7 ° | In distribution |
| 64635-008 | Length 24 mm | In distribution |
| 64636-117 | Height 17 mm | In distribution |
| 64618-109 | Length 30 mm | In distribution |
| 64616-012 | Height 12 mm | In distribution |
| 64928 | In distribution | |
| 64401-220 | Width 23 mm | In distribution |
| 64194-010 | Height 10 mm | In distribution |
| 64635-011 | Height 11 mm | In distribution |
| 64192-010 | Length 25 mm | In distribution |
| 64636-010 | Length 28 mm | In distribution |
| 64401-416 | Length 26 mm | In distribution |
| 64193-112 | Height 12 mm | In distribution |
| 64612-112 | Angle 5 ° | In distribution |
| 64675-114 | Height 14 mm | In distribution |
| 64403-208 | Angle 7 ° | In distribution |
| 64635-009 | Length 24 mm | In distribution |
| 64616-011 | Height 11 mm | In distribution |
| 64655-115 | Withdrawn | |
| 64679-113 | Withdrawn | |
| 64679-110 | Withdrawn | |
| 64677-107 | Withdrawn | |
| 64655-113 | Withdrawn | |
| 64655-111 | Withdrawn | |
| 64659-112 | Withdrawn | |
| 64659-111 | Withdrawn | |
| 64679-112 | Withdrawn | |
| 64679-106 | Withdrawn | |
| 64679-115 | Withdrawn | |
| 64679-108 | Withdrawn | |
| 64677-108 | Withdrawn | |
| 64659-115 | Withdrawn | |
| 64919 | Withdrawn | |
| 64677-112 | Withdrawn | |
| 64677-111 | Withdrawn | |
| 64655-110 | Withdrawn | |
| 64655-112 | Withdrawn | |
| 64675-111 | Withdrawn | |
| 64675-109 | Withdrawn | |
| 64675-112 | Withdrawn | |
| 64657-111 | Withdrawn | |
| 64657-107 | Withdrawn | |
| 64655-106 | Withdrawn | |
| 64679-109 | Withdrawn | |
| 64655-114 | Withdrawn | |
| 64657-110 | Withdrawn | |
| 64657-112 | Withdrawn | |
| 64675-106 | Withdrawn | |
| 64675-110 | Withdrawn | |
| 64679-107 | Withdrawn | |
| 64679-114 | Withdrawn | |
| 64677-109 | Withdrawn | |
| 64677-106 | Withdrawn | |
| 64677-110 | Withdrawn | |
| 64659-113 | Withdrawn | |
| 64657-114 | Withdrawn | |
| 64675-107 | Withdrawn | |
| 64655-107 | Withdrawn | |
| 64679-111 | Withdrawn | |
| 64659-109 | Withdrawn | |
| 64675-108 | Withdrawn | |
| 64659-110 | Withdrawn | |
| 64918 | Withdrawn |
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 |
|---|---|
| K241375 | 2025-02-03 |
| K242364 | 2024-10-04 |
| K242147 | 2024-09-20 |
| K232504 | 2023-10-13 |
| K231438 | 2023-07-13 |
| K223611 | 2023-03-29 |
| K222455 | 2022-11-18 |
| K222028 | 2022-10-07 |
| K220782 | 2022-06-09 |
| K211805 | 2021-09-22 |
| K211873 | 2021-08-10 |
| K202587 | 2020-11-06 |
| K191311 | 2019-08-12 |
| K183705 | 2019-03-01 |
| K182746 | 2018-11-27 |
| K181453 | 2018-07-25 |
| K160646 | 2016-08-24 |
| K143740 | 2015-05-22 |
| K130548 | 2013-04-18 |
| K090425 | 2009-05-19 |
| K090782 | 2009-04-22 |
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 |
|---|---|---|---|---|---|---|---|
| Alphatec Spine, Inc. | 510(k) number | 2009-05-13 | Not classified | Process control | Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant. | 37 devices | 2009-11-13 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2024-12-15 | Class II | Under Investigation by firm | Complaints have been received regarding post-operative implant collapse. | 1,127 loose implants; 10/24-implant kits; and 4/36-implant k | |
| 2012-03-19 | Not classified | Device Design | Alphatec Spine has received several complaints (n+4) on the Alphatec Solus Distal Deployment Wrench for twisting or bending, which has been discovered either during or after instrumentation use. A fifth complaint received in which it was re | 18 devices | 2012-06-20 |
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.