Altera
The ALTERA Spacer is an expandable lumbar interbody fusion device used to provide structural stability after discectomy in skeletally mature individuals. The filing says it accommodates…
The ALTERA Spacer is an expandable lumbar interbody fusion device used to provide structural stability after discectomy in skeletally mature individuals. The filing says it accommodates posterior or transforaminal approaches and can articulate during insertion.
The filing describes a range of available heights to fit anatomical needs. The device is to be filled with autogenous bone graft material, and its upper and lower surface protrusions grip adjacent vertebral endplates.
Listed Item
ALTERA Spacer, 10 x 36, 10-14mm, 15°
Device Construction
The FDA document identifies titanium alloy for the spacer and names radiolucent PEEK polymer and cobalt chromium molybdenum alloy for internal components. The stated indication includes degenerative disc disease at one or two contiguous lumbosacral levels.
14manufacturers in China registered for this device type
21catalogue 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) | K140411 |
| Record published | 2015-10-30 |
| 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 | Height 8 to 12 mm; length 26 to 36 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1124.1233 | Lordosis 15 Degree | In distribution |
| 1124.1113 | Lordosis 8 Degree | In distribution |
| 1124.1035 | Length 26 mm | In distribution |
| 1124.1015 | Lordosis 8 Degree | In distribution |
| 1124.1133 | Lordosis 15 Degree | In distribution |
| 1124.1111 | Length 31 mm | In distribution |
| 1124.1213 | Height 10 mm | In distribution |
| 1124.1215 | Lordosis 8 Degree | In distribution |
| 1124.1033 | Length 26 mm | In distribution |
| 1124.1013 | Lordosis 8 Degree | In distribution |
| 1124.1032 | Lordosis 15 Degree | In distribution |
| 1124.1112 | Height 9 mm | In distribution |
| 1124.1212 | Lordosis 8 Degree | In distribution |
| 1124.1235 | Length 36 mm | In distribution |
| 1124.1232 | Length 36 mm | In distribution |
| 1124.1211 | Height 8 mm | In distribution |
| 1124.1115 | Length 31 mm | In distribution |
| 1124.1012 | Height 9 mm | In distribution |
| 1124.1011 | Length 26 mm | In distribution |
| 1124.1135 | Lordosis 15 Degree | In distribution |
| 1124.1132 | Length 31 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 Naming This Product
22 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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 |
| Globus Medical, Inc. | 510(k) number | 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.