VerteLP Interbody Fusion Device
VerteLP is a lateral lumbar interbody fusion implant with central apertures for autograft bone. Integrated laterally locking jaws provide fixation to the adjacent vertebrae. The implant…
VerteLP is a lateral lumbar interbody fusion implant with central apertures for autograft bone. Integrated laterally locking jaws provide fixation to the adjacent vertebrae.
The implant combines titanium alloy, PEEK, ultra-high-molecular-weight polyethylene and tantalum components. Parallel and lordotic shapes and different dimensions accommodate the treated anatomy.
Listed Item
VerteLP Angled Implant Inserter Ball-end Hex Driver
Additional Fixation
The integrated jaws do not replace the requirement for supplemental fixation. VerteLP is used with autograft and additional fixation for one or two adjacent levels from L2 to L5 in skeletally mature patients. Associated instruments support lateral placement of the system.
3manufacturers in China registered for this device type
264catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | VGI medical, LLC, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K151312 |
| Record published | 2016-09-28 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Width 7 to 74 mm; length 11 to 74 mm; height 7 to 70 mm; angle 7 °; length 55 µm; height 8 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VG-LP-18X55X14(7) | Angle 7 ° | In distribution |
| VG-LP-22X50X8 | Width 22 mm | In distribution |
| VG-LP-18X45X9 | Length 45 mm | In distribution |
| VG-LP-22X40X13 | Width 22 mm | In distribution |
| VG-LP-22X70X15 | Width 22 mm | In distribution |
| VG-LP-18X70X14(7) | Width 18 mm | In distribution |
| VG-LP-22X55X12(7) | Angle 7 ° | In distribution |
| VG-LP-22X65X14 | Width 22 mm | In distribution |
| VG-LP-22X60X9 | Width 22 mm | In distribution |
| VG-LP-22X60X17(7) | Width 22 mm | In distribution |
| VG-LP-22X65X8 | Width 22 mm | In distribution |
| VG-LP-18X40X11(7) | Length 40 mm | In distribution |
| VG-LP-18X45X9(7) | Length 49 mm | In distribution |
| VG-LP-22X70X11(7) | Angle 7 ° | In distribution |
| VG-LP-22X55X8 | Width 22 mm | In distribution |
| VG-LP-22X55X17(7) | Angle 7 ° | In distribution |
| VG-LP-22X60X7 | Width 22 mm | In distribution |
| VG-LP-22X50X10 | Width 22 mm | In distribution |
| VG-LP-18x40x11 | Length 40 mm | In distribution |
| VG-LP-18X40X14(7) | Length 40 mm | In distribution |
| VG-LP-18x40x9 | Length 40 mm | In distribution |
| VG-LP-22X60X9(7) | Width 22 mm | In distribution |
| VG-LP-18X70X13(7) | Angle 7 ° | In distribution |
| VG-LP-22X50X11(7) | Angle 7 ° | In distribution |
| VG-LP-18X55X10(7) | Length 55 mm | In distribution |
| VG-LP-18X45X11(7) | Length 45 mm | In distribution |
| VG-LP-18X55X8 | Length 59 mm | In distribution |
| VG-LP-22X70X9(7) | Angle 7 ° | In distribution |
| VG-LP-18X45X14 | Length 45 mm | In distribution |
| VG-LP-22X60X8(7) | Angle 7 ° | In distribution |
| VG-LP-22X55X15 | Width 22 mm | In distribution |
| VG-LP-18X60X11 | Length 60 mm | In distribution |
| VG-LP-22X60X12(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X9 | Length 70 mm | In distribution |
| VG-LP-22X45X14(7) | Angle 7 ° | In distribution |
| VG-LP-18X60X14(7) | Width 18 mm | In distribution |
| VG-LP-18X55X15 | Length 55 µm | In distribution |
| VG-LP-22X50X9 | Width 22 mm | In distribution |
| VG-LP-22X70X16 | Width 22 mm | In distribution |
| VG-LP-22X55X9 | Width 22 mm | In distribution |
| VG-LP-22X70X14(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X15(7) | Width 18 mm | In distribution |
| VG-LP-18x40x14 | Length 40 mm | In distribution |
| VG-LP-22X50X7 | Width 22 mm | In distribution |
| VG-LP-18X45X8(7) | Length 49 mm | In distribution |
| VG-LP-18X60X7 | Length 64 mm | In distribution |
| VG-LP-22X40X9 | Width 22 mm | In distribution |
| VG-LP-22X40X12(7) | Angle 7 ° | In distribution |
| VG-LP-22X65X13(7) | Angle 7 ° | In distribution |
| VG-LP-18X50X9 | Length 50 mm | In distribution |
| VG-LP-22X45X10 | Width 22 mm | In distribution |
| VG-LP-22X50X9(7) | Angle 7 ° | In distribution |
| VG-LP-18X65X14 | Width 18 mm | In distribution |
| VG-LP-22X60X15(7) | Angle 7 ° | In distribution |
| VG-LP-18X50X14 | Length 50 mm | In distribution |
| VG-LP-22X70X17(7) | Width 22 mm | In distribution |
| VG-LP-22X45X10(7) | Angle 7 ° | In distribution |
| VG-LP-22X45X15(7) | Angle 7 ° | In distribution |
| VG-LP-22X55X11 | Width 22 mm | In distribution |
| VG-LP-22X45X13 | Width 22 mm | In distribution |
| VG-LP-22X40X8 | Width 22 mm | In distribution |
| VG-LP-18X55X12(7) | Length 55 mm | In distribution |
| VG-LP-18X70X9(7) | Width 18 mm | In distribution |
| VG-LP-22X45X14 | Width 22 mm | In distribution |
| VG-LP-22X55X11(7) | Angle 7 ° | In distribution |
| VG-LP-22X45X13(7) | Angle 7 ° | In distribution |
| VG-LP-22X65X13 | Width 22 mm | In distribution |
| VG-LP-22X40X7 | Width 22 mm | In distribution |
| VG-LP-22X45X8 | Width 22 mm | In distribution |
| VLP-INSTRANG | In distribution | |
| VG-LP-18X65X12 | Length 65 mm | In distribution |
| VG-LP-18X65X9(7) | Angle 7 ° | In distribution |
| VG-LP-18X45X15(7) | Angle 7 ° | In distribution |
| VG-LP-18x40x10 | Length 40 mm | In distribution |
| VG-LP-18X60X13(7) | Width 18 mm | In distribution |
| VG-LP-18X50X13 | Length 50 mm | In distribution |
| VG-LP-22X50X12 | Width 22 mm | In distribution |
| VG-LP-22X55X13(7) | Angle 7 ° | In distribution |
| VG-LP-18X65X7 | Length 69 mm | In distribution |
| VG-LP-22X40X8(7) | Angle 7 ° | In distribution |
| VG-LP-22X40X15(7) | Angle 7 ° | In distribution |
| VG-LP-18X55X8(7) | Angle 7 ° | In distribution |
| VG-LP-22X55X12 | Width 22 mm | In distribution |
| VG-LP-18X45X14(7) | Length 45 mm | In distribution |
| VG-LP-18X55X9 | Length 55 mm | In distribution |
| VG-LP-22X45X17 | Width 22 mm | In distribution |
| VG-LP-22X40X14 | Width 22 mm | In distribution |
| VG-LP-22X65X8(7) | Angle 7 ° | In distribution |
| VG-LP-18X60X11(7) | Angle 7 ° | In distribution |
| VG-LP-22X40X11 | Width 22 mm | In distribution |
| VG-LP-22X65X11(7) | Angle 7 ° | In distribution |
| VG-LP-22X50X15(7) | Angle 7 ° | In distribution |
| VG-LP-18X65X8 | Length 69 mm | In distribution |
| VG-LP-18X55X11(7) | Length 55 mm | In distribution |
| VG-LP-18X60X8(7) | Length 64 mm | In distribution |
| VG-LP-22X70X12 | Width 22 mm | In distribution |
| VG-LP-22X55X7 | Width 74 mm | In distribution |
| VG-LP-18X60X10 | Length 60 mm | In distribution |
| VG-LP-22X50X13(7) | Angle 7 ° | In distribution |
| VG-LP-22X70X16(7) | Width 22 mm | In distribution |
| VG-LP-22X60X15 | Width 22 mm | In distribution |
| VG-LP-22X65X9 | Width 22 mm | In distribution |
| VG-LP-22X55X13 | Width 22 mm | In distribution |
| VG-LP-22X45X110 | Width 22 mm | In distribution |
| VG-LP-18X40X7 | Length 44 mm | In distribution |
| VG-LP-18X50X9(7) | Angle 7 ° | In distribution |
| VG-LP-22X70X17 | Width 22 mm | In distribution |
| VG-LP-22X50X16 | Width 22 mm | In distribution |
| VG-LP-18X60X13 | Length 60 mm | In distribution |
| VG-LP-22X55X9(7) | Angle 7 ° | In distribution |
| VG-LP-22X65X15(7) | Angle 7 ° | In distribution |
| VG-LP-22X65X14(7) | Angle 7 ° | In distribution |
| VG-LP-18X45X13(7) | Length 45 mm | In distribution |
| VG-LP-22X60X17 | Width 22 mm | In distribution |
| VG-LP-22X50X10(7) | Angle 7 ° | In distribution |
| VG-LP-18X55X15(7) | Angle 7 ° | In distribution |
| VG-LP-22X65X10(7) | Angle 7 ° | In distribution |
| VG-LP-18X50X11(7) | Length 50 mm | In distribution |
| VG-LP-18X65X14(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X15 | Length 70 mm | In distribution |
| VG-LP-22X65X17(7) | Angle 7 ° | In distribution |
| VG-LP-22X60X10 | Width 22 mm | In distribution |
| VG-LP-22X50X16(7) | Angle 7 ° | In distribution |
| VG-LP-18X45X11 | Length 45 mm | In distribution |
| VG-LP-22X65X12(7) | Angle 7 ° | In distribution |
| VG-LP-22X45X11(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X8(7) | Width 18 mm | In distribution |
| VG-LP-18X50X12(7) | Angle 7 ° | In distribution |
| VG-LP-18X60X15 | Width 18 mm | In distribution |
| VG-LP-22X65X12 | Width 22 mm | In distribution |
| VG-LP-18X70X13 | Length 70 mm | In distribution |
| VG-LP-22X65X16 | Width 22 mm | In distribution |
| VG-LP-22X50X13 | Width 22 mm | In distribution |
| VG-LP-18X40X8(7) | Length 44 mm | In distribution |
| VG-LP-22X40X13(7) | Angle 7 ° | In distribution |
| VG-LP-18x40x8 | Length 44 mm | In distribution |
| VG-LP-18X65X15(7) | Width 18 mm | In distribution |
| VG-LP-22X55X16 | Width 22 mm | In distribution |
| VG-LP-18X65X11(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X11(7) | Length 70 mm | In distribution |
| VG-LP-18X50X7 | Length 54 mm | In distribution |
| VG-LP-22X65X15 | Width 22 mm | In distribution |
| VG-LP-18X60X15(7) | Angle 7 ° | In distribution |
| VG-LP-18X65X9 | Length 65 mm | In distribution |
| VG-LP-22X65X9(7) | Angle 7 ° | In distribution |
| VG-LP-18X65X13(7) | Width 18 mm | In distribution |
| VG-LP-18X50X10 | Length 50 mm | In distribution |
| VG-LP-22X60X8 | Width 22 mm | In distribution |
| VG-LP-22X70X8 | Width 22 mm | In distribution |
| VG-LP-18X50X8(7) | Angle 7 ° | In distribution |
| VG-LP-22X45X16(7) | Angle 7 ° | In distribution |
| VG-LP-22X40X15 | Width 22 mm | In distribution |
| VG-LP-22X65X7 | Width 22 mm | In distribution |
| VG-LP-22X60X14(7) | Angle 7 ° | In distribution |
| VG-LP-18X50X15(7) | Length 50 mm | In distribution |
| VG-LP-18X70X11 | Length 70 mm | In distribution |
| VG-LP-22X40X10(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X14 | Length 70 mm | In distribution |
| VG-LP-18X55X12 | Length 55 mm | In distribution |
| VG-LP-18X45X15 | Length 45 mm | In distribution |
| VG-LP-18x40x13 | Length 40 mm | In distribution |
| VG-LP-18X60X14 | Length 60 mm | In distribution |
| VG-LP-22X55X14 | Width 22 mm | In distribution |
| VG-LP-18X55X13(7) | Length 55 mm | In distribution |
| VG-LP-18X60X12(7) | Length 60 mm | In distribution |
| VG-LP-18X50X12 | Length 50 mm | In distribution |
| VG-LP-18X45X10(7) | Length 45 mm | In distribution |
| VLP-BALLHEX | In distribution | |
| VG-LP-22X45X12(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X10 | Length 70 mm | In distribution |
| VG-LP-18X55X9(7) | Length 59 mm | In distribution |
| VG-LP-22X60X16(7) | Angle 7 ° | In distribution |
| VG-LP-22X40X10 | Width 22 mm | In distribution |
| VG-LP-18X60X8 | Length 64 mm | In distribution |
| VG-LP-22X50X14(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X12 | Length 70 mm | In distribution |
| VG-LP-22X50X17 | Width 22 mm | In distribution |
| VG-LP-22X60X11(7) | Angle 7 ° | In distribution |
| VG-LP-18X70X7 | Length 74 mm | In distribution |
| VG-LP-22X70X9 | Width 22 mm | In distribution |
| VG-LP-18X65X10 | Length 65 mm | In distribution |
| VG-LP-22X65X10 | Width 22 mm | In distribution |
| VG-LP-22X70X14 | Width 22 mm | In distribution |
| VG-LP-18X60X12 | Length 60 mm | In distribution |
| VG-LP-22X45X90 | Width 22 mm | In distribution |
| VG-LP-18X65X8(7) | Angle 7 ° | In distribution |
| VG-LP-18X50X8 | Length 54 mm | In distribution |
| VG-LP-18X60X10(7) | Length 60 mm | In distribution |
| VG-LP-22X55X16(7) | Angle 7 ° | In distribution |
| VG-LP-22X55X10 | Width 22 mm | In distribution |
| VG-LP-22X40X11(7) | Angle 7 ° | In distribution |
| VG-LP-22X55X17 | Width 22 mm | In distribution |
| VG-LP-22X45X16 | Width 22 mm | In distribution |
| VG-LP-18X50X13(7) | Length 50 mm | In distribution |
| VG-LP-18X65X15 | Length 65 mm | In distribution |
| VG-LP-18x40x12 | Length 40 mm | In distribution |
| VG-LP-22X70X15(7) | Angle 7 ° | In distribution |
| VG-LP-22X65X11 | Width 22 mm | In distribution |
| VG-LP-18X45X12(7) | Length 45 mm | In distribution |
| VG-LP-18X45X7 | Length 49 mm | In distribution |
| VG-LP-22X40X14(7) | Angle 7 ° | In distribution |
| VG-LP-22X50X15 | Width 22 mm | In distribution |
| VG-LP-22X50X12(7) | Angle 7 ° | In distribution |
| VG-LP-22X50X14 | Width 22 mm | In distribution |
| VG-LP-22X40X9(7) | Angle 7 ° | In distribution |
| VG-LP-18X40X12(7) | Angle 7 ° | In distribution |
| VG-LP-18X50X10(7) | Angle 7 ° | In distribution |
| VG-LP-22X50X17(7) | Angle 7 ° | In distribution |
| VG-LP-22X55X7 | Width 22 mm | In distribution |
| VG-LP-18X40X13(7) | Length 40 mm | In distribution |
| VG-LP-22X40X12 | Width 22 mm | In distribution |
| VG-LP-22X70X11 | Width 22 mm | In distribution |
| VG-LP-18X65X10(7) | Width 18 mm | In distribution |
| VG-LP-18X70X12(7) | Width 18 mm | In distribution |
| VG-LP-22X70X13(7) | Angle 7 ° | In distribution |
| VG-LP-22X70X12(7) | Angle 7 ° | In distribution |
| VG-LP-18X40X9(7) | Angle 7 ° | In distribution |
| VG-LP-22X65X17 | Width 22 mm | In distribution |
| VG-LP-22X60X11 | Width 22 mm | In distribution |
| VG-LP-22X45X7 | Width 22 mm | In distribution |
| VG-LP-22X55X8(7) | Angle 7 ° | In distribution |
| VG-LP-22X70X10(7) | Height 10 mm | In distribution |
| VG-LP-18X40X15(7) | Length 40 mm | In distribution |
| VG-LP-22X60X13(7) | Angle 7 ° | In distribution |
| VG-LP-18X45X10 | Length 45 mm | In distribution |
| VG-LP-18X50X14(7) | Length 50 mm | In distribution |
| VG-LP-22X70X8(7) | Angle 7 ° | In distribution |
| VG-LP-22X45X8(7) | Angle 7 ° | In distribution |
| VG-LP-22X60X10(7) | Angle 7 ° | In distribution |
| VG-LP-22X50X8(7) | Angle 7 ° | In distribution |
| VG-LP-18X60X9 | Length 60 mm | In distribution |
| VG-LP-18X70X8 | Length 74 mm | In distribution |
| VG-LP-18x40x15 | Length 40 mm | In distribution |
| VG-LP-22X55X15(7) | Angle 7 ° | In distribution |
| VG-LP-22X45X9(7) | Angle 7 ° | In distribution |
| VG-LP-18X55X10 | Length 55 mm | In distribution |
| VG-LP-22X55X10(7) | Angle 7 ° | In distribution |
| VG-LP-18X55X14 | Length 55 mm | In distribution |
| VG-LP-22X45X15 | Width 22 mm | In distribution |
| VG-LP-18X60X9(7) | Length 64 mm | In distribution |
| VG-LP-18X65X13 | Length 65 mm | In distribution |
| VG-LP-18X50X15 | Length 50 mm | In distribution |
| VG-LP-22X60X16 | Width 22 mm | In distribution |
| VG-LP-18X50X11 | Length 50 mm | In distribution |
| VG-LP-18X55X13 | Length 55 mm | In distribution |
| VG-LP-18X45X8 | Length 49 mm | In distribution |
| VG-LP-18X55X11 | Length 55 mm | In distribution |
| VG-LP-22X70X10 | Width 22 mm | In distribution |
| VG-LP-18X45X12 | Length 45 mm | In distribution |
| VG-LP-22X65X16(7) | Angle 7 ° | In distribution |
Showing 250 of 264 catalogue numbers.
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| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151312 | 2016-01-13 |
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 |
|---|---|---|---|---|---|---|---|
| VGI medical, LLC | 510(k) number | 2018-04-09 | Class II | Process design | IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated | 6 units | 2020-08-21 |
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.