Rise
The FDA summary describes RISE spacers as lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers come in…
The FDA summary describes RISE spacers as lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy.
The spacers come in shapes for posterior, transforaminal or lateral approaches and can expand to a desired height.
Listed Item
RISE-L Spacer 22 x 60mm, 10-17mm, 10deg
Indications
The filing indicates use for degenerative disc disease at one or two contiguous lumbosacral levels in skeletally mature patients after at least six months of nonoperative treatment.
14manufacturers in China registered for this device type
70catalogue numbers in this listing
20510(k) clearances naming this product code
22recalls 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 | Globus Medical, 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 | Manufacturer, Exporter |
| 510(k) | K113447 |
| Record published | 2015-11-07 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Width 8 to 22 mm; length 22 to 60 mm; height 7 to 11 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 193.002 | Width 8 mm | In distribution |
| 193.436 | Length 60 mm | In distribution |
| 193.001 | Height 7 mm | In distribution |
| 193.041 | Width 8 mm | In distribution |
| 193.102 | Height 7 mm | In distribution |
| 193.142 | Lordosis 15 Degree | In distribution |
| 193.212 | Width 12 mm | In distribution |
| 193.435 | Height 10 mm | In distribution |
| 193.426 | Height 8 mm | In distribution |
| 193.412 | Length 40 mm | In distribution |
| 193.011 | Height 11 mm | In distribution |
| 193.151 | Width 10 mm | In distribution |
| 193.434 | Width 22 mm | In distribution |
| 193.316 | Length 60 mm | In distribution |
| 193.424 | Lordosis 6 Degree | In distribution |
| 193.406 | Length 60 mm | In distribution |
| 193.333 | Length 45 mm | In distribution |
| 193.223 | Length 30 mm | In distribution |
| 193.402 | Width 22 mm | In distribution |
| 193.313 | Width 18 mm | In distribution |
| 193.222 | Width 12 mm | In distribution |
| 193.403 | Width 22 mm | In distribution |
| 193.415 | Height 10 mm | In distribution |
| 193.051 | Width 8 mm | In distribution |
| 193.031 | Lordosis 15 Degree | In distribution |
| 193.021 | Width 8 mm | In distribution |
| 193.112 | Height 10 mm | In distribution |
| 193.202 | Length 26 mm | In distribution |
| 193.413 | Width 22 mm | In distribution |
| 193.414 | Length 50 mm | In distribution |
| 193.243 | Width 12 mm | In distribution |
| 193.113 | Width 10 mm | In distribution |
| 193.324 | Width 18 mm | In distribution |
| 193.003 | Height 7 mm | In distribution |
| 193.304 | Height 7 mm | In distribution |
| 193.303 | Height 7 mm | In distribution |
| 193.432 | Height 10 mm | In distribution |
| 193.122 | Height 8 mm | In distribution |
| 193.213 | Length 30 mm | In distribution |
| 193.314 | Width 18 mm | In distribution |
| 193.332 | Length 40 mm | In distribution |
| 193.325 | Width 18 mm | In distribution |
| 193.143 | Height 10 mm | In distribution |
| 193.302 | Height 7 mm | In distribution |
| 193.123 | Length 30 mm | In distribution |
| 193.141 | Length 22 mm | In distribution |
| 193.305 | Height 7 mm | In distribution |
| 193.121 | Width 10 mm | In distribution |
| 193.242 | Length 26 mm | In distribution |
| 193.335 | Height 10 mm | In distribution |
| 193.326 | Lordosis 6 Degree | In distribution |
| 193.322 | Lordosis 6 Degree | In distribution |
| 193.336 | Length 60 mm | In distribution |
| 193.101 | Height 7 mm | In distribution |
| 193.203 | Width 12 mm | In distribution |
| 193.433 | Width 22 mm | In distribution |
| 193.422 | Length 40 mm | In distribution |
| 193.312 | Length 40 mm | In distribution |
| 193.405 | Length 55 mm | In distribution |
| 193.315 | Height 10 mm | In distribution |
| 193.103 | Width 10 mm | In distribution |
| 193.404 | Width 22 mm | In distribution |
| 193.306 | Width 18 mm | In distribution |
| 193.323 | Height 8 mm | In distribution |
| 193.416 | Length 60 mm | In distribution |
| 193.334 | Height 10 mm | In distribution |
| 193.111 | Width 10 mm | In distribution |
| 193.423 | Length 45 mm | In distribution |
| 193.425 | Length 55 mm | In distribution |
| 193.004 | Length 34 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K234035 | 2024-09-06 |
| K221894 | 2023-08-03 |
| K203278 | 2021-02-02 |
| K192115 | 2020-01-14 |
| K191391 | 2019-09-18 |
| K181357 | 2018-12-06 |
| K171848 | 2017-12-21 |
| K152022 | 2017-02-22 |
| K143578 | 2016-04-13 |
| K151665 | 2016-03-16 |
| K140411 | 2014-07-01 |
| K130478 | 2013-07-26 |
| K123913 | 2013-05-13 |
| K123231 | 2013-01-18 |
| K122097 | 2012-12-06 |
| K113447 | 2012-01-26 |
| K102293 | 2011-01-05 |
| K102313 | 2010-12-03 |
| K093242 | 2009-12-23 |
| K072970 | 2008-01-18 |
Recalls
22 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 | Closed |
|---|---|---|---|---|
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
| 2020-07-22 | Class II | Nonconforming Material/Component | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | 2021-08-19 |
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.