Ascent LE
3.0MM TO 5.5MM Transition ROD, 200MM X 200MM, Ascent LE Poct
11manufacturers in China registered for this device type
204catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K111183 |
| Record published | 2019-03-19 |
| Record revised | 2026-02-20 (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 | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66-2200 | In distribution | |
| 66-3622 | In distribution | |
| 66-3712 | In distribution | |
| 66-3248 | In distribution | |
| 66-3448 | In distribution | |
| 66-3330 | In distribution | |
| 66-3518 | In distribution | |
| 66-3520 | In distribution | |
| 66-3442 | In distribution | |
| 66-3828 | In distribution | |
| 66-3824 | In distribution | |
| 66-3128 | In distribution | |
| 66-3316 | In distribution | |
| 65-5335 | In distribution | |
| 66-3124 | In distribution | |
| 66-3638 | In distribution | |
| 66-3616 | In distribution | |
| 66-3628 | In distribution | |
| 66-3748 | In distribution | |
| 67-3010 | In distribution | |
| 66-2020 | In distribution | |
| 66-3612 | In distribution | |
| 66-3230 | In distribution | |
| 66-3538 | In distribution | |
| 66-3328 | In distribution | |
| 66-3136 | In distribution | |
| 66-3724 | In distribution | |
| 66-3632 | In distribution | |
| 65-2010 | In distribution | |
| 66-3834 | In distribution | |
| 66-3332 | In distribution | |
| 66-2060 | In distribution | |
| 66-2006 | In distribution | |
| 66-3514 | In distribution | |
| 66-3140 | In distribution | |
| 66-3626 | In distribution | |
| 66-3512 | In distribution | |
| 66-3412 | In distribution | |
| 66-2120 | In distribution | |
| 66-3144 | In distribution | |
| 65-2008 | In distribution | |
| 66-3322 | In distribution | |
| 66-2062 | In distribution | |
| 66-3550 | In distribution | |
| 66-3832 | In distribution | |
| 66-3850 | In distribution | |
| 66-3526 | In distribution | |
| 66-3752 | In distribution | |
| 66-3840 | In distribution | |
| 66-3846 | In distribution | |
| 66-3552 | In distribution | |
| 65-5340 | In distribution | |
| 65-2002 | In distribution | |
| 66-3444 | In distribution | |
| 66-3826 | In distribution | |
| 66-3132 | In distribution | |
| 66-3232 | In distribution | |
| 66-3818 | In distribution | |
| 66-3118 | In distribution | |
| 66-3152 | In distribution | |
| 66-3810 | In distribution | |
| 66-3246 | In distribution | |
| 66-3422 | In distribution | |
| 66-3424 | In distribution | |
| 66-3720 | In distribution | |
| 66-3252 | In distribution | |
| 66-3350 | In distribution | |
| 66-3318 | In distribution | |
| 66-3420 | In distribution | |
| 66-3446 | In distribution | |
| 66-3650 | In distribution | |
| 66-3730 | In distribution | |
| 66-3348 | In distribution | |
| 66-2030 | In distribution | |
| 66-3838 | In distribution | |
| 65-6425 | In distribution | |
| 65-2014 | In distribution | |
| 66-3610 | In distribution | |
| 66-3138 | In distribution | |
| 66-3418 | In distribution | |
| 66-3338 | In distribution | |
| 66-3642 | In distribution | |
| 66-3342 | In distribution | |
| 66-3528 | In distribution | |
| 66-3816 | In distribution | |
| 66-3640 | In distribution | |
| 66-3030 | In distribution | |
| 66-3842 | In distribution | |
| 65-2006 | In distribution | |
| 66-3624 | In distribution | |
| 66-3830 | In distribution | |
| 66-3324 | In distribution | |
| 66-3516 | In distribution | |
| 66-3340 | In distribution | |
| 66-3728 | In distribution | |
| 66-3648 | In distribution | |
| 66-3548 | In distribution | |
| 66-3220 | In distribution | |
| 66-3732 | In distribution | |
| 66-2008 | In distribution | |
| 66-3636 | In distribution | |
| 66-3218 | In distribution | |
| 66-3346 | In distribution | |
| 66-3240 | In distribution | |
| 66-3652 | In distribution | |
| 66-3530 | In distribution | |
| 66-3438 | In distribution | |
| 66-2061 | In distribution | |
| 66-3844 | In distribution | |
| 66-3750 | In distribution | |
| 66-2070 | In distribution | |
| 66-3634 | In distribution | |
| 66-3546 | In distribution | |
| 66-2041 | In distribution | |
| 65-5330 | In distribution | |
| 66-3738 | In distribution | |
| 66-3814 | In distribution | |
| 66-3244 | In distribution | |
| 66-3146 | In distribution | |
| 66-3822 | In distribution | |
| 66-2040 | In distribution | |
| 66-3320 | In distribution | |
| 66-2014 | In distribution | |
| 66-3130 | In distribution | |
| 66-2012 | In distribution | |
| 66-3740 | In distribution | |
| 65-2200 | In distribution | |
| 66-3352 | In distribution | |
| 66-3134 | In distribution | |
| 66-3344 | In distribution | |
| 66-3852 | In distribution | |
| 66-3234 | In distribution | |
| 66-3236 | In distribution | |
| 65-5345 | In distribution | |
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| 66-3122 | In distribution | |
| 66-3836 | In distribution | |
| 66-3440 | In distribution | |
| 66-3312 | In distribution | |
| 66-3148 | In distribution | |
| 66-3416 | In distribution | |
| 66-3250 | In distribution | |
| 66-3510 | In distribution | |
| 66-3744 | In distribution | |
| 67-3011 | In distribution | |
| 66-3812 | In distribution | |
| 66-3228 | In distribution | |
| 65-6310 | In distribution | |
| 66-3536 | In distribution | |
| 66-3848 | In distribution | |
| 65-5320 | In distribution | |
| 66-3522 | In distribution | |
| 66-3436 | In distribution | |
| 66-3524 | In distribution | |
| 66-3310 | In distribution | |
| 66-3410 | In distribution | |
| 66-3434 | In distribution | |
| 66-3430 | In distribution | |
| 66-3716 | In distribution | |
| 66-3614 | In distribution | |
| 66-3326 | In distribution | |
| 66-3242 | In distribution | |
| 66-3126 | In distribution | |
| 66-3714 | In distribution | |
| 66-3736 | In distribution | |
| 66-3222 | In distribution | |
| 66-3710 | In distribution | |
| 66-3726 | In distribution | |
| 66-2010 | In distribution | |
| 66-3644 | In distribution | |
| 66-3226 | In distribution | |
| 65-5350 | In distribution | |
| 66-3414 | In distribution | |
| 66-3820 | In distribution | |
| 66-2042 | In distribution | |
| 66-3718 | In distribution | |
| 66-3746 | In distribution | |
| 66-2043 | In distribution | |
| 66-3630 | In distribution | |
| 66-3450 | In distribution | |
| 66-3534 | In distribution | |
| 66-3120 | In distribution | |
| 66-3150 | In distribution | |
| 66-3544 | In distribution | |
| 66-3426 | In distribution | |
| 66-3734 | In distribution | |
| 66-3742 | In distribution | |
| 66-3540 | In distribution | |
| 66-3532 | In distribution | |
| 66-3428 | In distribution | |
| 66-3334 | In distribution | |
| 66-3646 | In distribution | |
| 66-3618 | In distribution | |
| 65-2120 | In distribution | |
| 66-3336 | In distribution | |
| 66-3452 | In distribution | |
| 66-3542 | In distribution | |
| 66-3142 | In distribution | |
| 66-3620 | In distribution | |
| 66-3432 | In distribution | |
| 66-3238 | In distribution | |
| 66-3224 | In distribution | |
| 66-3314 | In distribution | |
| 66-3722 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
Recalls
2 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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-11-26 | Class II | Nonconforming Material/Component | Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver’s collet would malfunction | 443 | 2014-12-09 |
| 2013-02-01 | Class II | Device Design | There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700) may crack during final tightening. Orthofix Inc received six (6) customer compla | 565 total (287 PN 52-6800 and 278 PN 52- 6700) | 2013-07-01 |
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.