Monterey AL
AL Implant Inserter Inner Shaft
14manufacturers in China registered for this device type
76catalogue numbers in this listing
17510(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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2022-04-14 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Height 8 to 22 mm; width 33 to 40 mm; angle 10 to 30 °; depth 25 to 34 mm; length 17.5 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 480114530 | Width 33.0 mm | In distribution |
| 480114535 | Angle 15.0 ° | In distribution |
| 480120105 | Angle 15.0 ° | In distribution |
| 480114401 | Depth 34.0 mm | In distribution |
| 480112165 | Height 12.0 mm | In distribution |
| 480116860 | Depth 28.0 mm | In distribution |
| 480114531 | Angle 10.0 ° | In distribution |
| 480118160 | Angle 10.0 ° | In distribution |
| 480112865 | Depth 28.0 mm | In distribution |
| 480112101 | Angle 10.0 ° | In distribution |
| 480114105 | Width 40.0 mm | In distribution |
| 480114861 | Height 14.0 mm | In distribution |
| 480116025 | Diameter: 6.0 Millimeter | In distribution |
| 480118860 | Depth 28.0 mm | In distribution |
| 480120533 | Depth 25.0 mm | In distribution |
| 48019100 | Height 12.0 mm | In distribution |
| 480122100 | Angle 20.0 ° | In distribution |
| 480116535 | Depth 25.0 mm | In distribution |
| 480120401 | Depth 34.0 mm | In distribution |
| 480120862 | Width 36.0 mm | In distribution |
| 480112861 | Depth 28.0 mm | In distribution |
| 480115525 | Length 25.0 mm | In distribution |
| 480114101 | Depth 31.0 mm | In distribution |
| 480116405 | Height 16.0 mm | In distribution |
| 480110101 | Depth 31.0 mm | In distribution |
| 480120162 | Depth 31.0 mm | In distribution |
| 480122103 | Angle 30.0 ° | In distribution |
| 480116531 | Width 33.0 mm | In distribution |
| 48019150 | Height 8.0 mm | In distribution |
| 48019130 | Height 20.0 mm | In distribution |
| 480120402 | Angle 25.0 ° | In distribution |
| 480116017 | Length 17.5 mm | In distribution |
| 480115530 | Diameter: 5.5 Millimeter | In distribution |
| 480120860 | Depth 28.0 mm | In distribution |
| 480116020 | Diameter: 6.0 Millimeter | In distribution |
| 480118162 | Width 36.0 mm | In distribution |
| 480114161 | Width 36.0 mm | In distribution |
| 480122863 | Width 36.0 mm | In distribution |
| 480120861 | Angle 10.0 ° | In distribution |
| 480118105 | Angle 15.0 ° | In distribution |
| 480118531 | Angle 10.0 ° | In distribution |
| 480122860 | Height 22.0 mm | In distribution |
| 480118405 | Depth 34.0 mm | In distribution |
| 480120163 | Width 36.0 mm | In distribution |
| 480118161 | Depth 31.0 mm | In distribution |
| 480118101 | Depth 31.0 mm | In distribution |
| 480108161 | Height 8.0 mm | In distribution |
| 480110861 | Depth 28.0 mm | In distribution |
| 480118532 | Angle 25.0 ° | In distribution |
| 480120400 | Depth 34.0 mm | In distribution |
| 480118530 | Angle 20.0 ° | In distribution |
| 480116165 | Height 16.0 mm | In distribution |
| 480118865 | Depth 28.0 mm | In distribution |
| 480116865 | Depth 28.0 mm | In distribution |
| 480118862 | Angle 25.0 ° | In distribution |
| 480118165 | Angle 15.0 ° | In distribution |
| 480112535 | Width 33.0 mm | In distribution |
| 480116101 | Angle 10.0 ° | In distribution |
| 480120531 | Depth 25.0 mm | In distribution |
| 480115017 | Diameter: 5.0 Millimeter | In distribution |
| 480118401 | Width 40.0 mm | In distribution |
| 48019140 | Height 22.0 mm | In distribution |
| 480110531 | Depth 25.0 mm | In distribution |
| 480122862 | Depth 28.0 mm | In distribution |
| 480112531 | Angle 10.0 ° | In distribution |
| 48019120 | Height 16.0 mm | In distribution |
| 480120535 | Width 33.0 mm | In distribution |
| 480120405 | Depth 34.0 mm | In distribution |
| 480120863 | Height 20.0 mm | In distribution |
| 480120101 | Depth 31.0 mm | In distribution |
| 48019151 | Height 8.0 mm | In distribution |
| 480116401 | Depth 34.0 mm | In distribution |
| 480116161 | Height 16.0 mm | In distribution |
| 480118100 | Angle 20.0 ° | In distribution |
| 480114165 | Angle 15.0 ° | In distribution |
| 480115517 | Length 17.5 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 |
|---|---|
| K200613 | 2020-04-15 |
| K173476 | 2018-01-18 |
| K162262 | 2016-11-09 |
| K160955 | 2016-07-21 |
| K160715 | 2016-07-08 |
| K151726 | 2016-01-20 |
| K152651 | 2015-12-15 |
| K152304 | 2015-11-19 |
| K143616 | 2015-03-05 |
| K141217 | 2014-07-16 |
| K093864 | 2010-03-11 |
| K093704 | 2009-12-23 |
| K090816 | 2009-04-24 |
| K090166 | 2009-04-22 |
| K083661 | 2009-02-27 |
| K082014 | 2008-07-28 |
| K080758 | 2008-03-27 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Spine | UDI-DI | 2025-02-28 | Class II | Device Design | Potential for the gold unlock button to separate from the inserter. | 64 units (60 US, 4 OUS) |
| Stryker Spine | UDI-DI | 2025-02-28 | Class II | Device Design | Potential for the gold unlock button to separate from the inserter. | 56 units (53 US, 3 OUS) |
| Stryker Spine | UDI-DI | 2025-02-28 | Class II | Device Design | Potential for the gold unlock button to separate from the inserter. | 46 units (44 US, 2 OUS) |
| Stryker Spine | UDI-DI | 2025-02-28 | Class II | Device Design | Potential for the gold unlock button to separate from the inserter. | 44 units (41 US, 3 OUS) |
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.