Ascend
16 mm CORE ENDPLATE, LAT 22 x 25 mm 10°
6manufacturers in China registered for this device type
143catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| K-MED Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 20 |
| Zhejiang Sorfa Life Science Research Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Xiamen Aquatown Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 5 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | MPQ |
| Device type | Container, Specimen, Urine, Drugs Of Abuse, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3260 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232173 |
| Record published | 2023-12-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 153-16-L-205000-S | In distribution | |
| 153-16-L-165000-S | In distribution | |
| 153-16-L-222510-S | In distribution | |
| 153-16-B-185005-S | In distribution | |
| 153-16-L-224505-S | In distribution | |
| 153-16-L-163000-S | In distribution | |
| 153-16-L-223000-S | In distribution | |
| 153-16-L-186000-S | In distribution | |
| 153-16-L-225000-S | In distribution | |
| 153-16-B-162510-S | In distribution | |
| 153-16-L-224510-S | In distribution | |
| 153-16-L-223005-S | In distribution | |
| 153-16-B-162505-S | In distribution | |
| 153-16-L-206000-S | In distribution | |
| 153-16-L-182500-S | In distribution | |
| 153-16-R-200005-S | In distribution | |
| 153-16-R-280000-S | In distribution | |
| 153-16-L-183510-S | In distribution | |
| 153-16-B-183005-S | In distribution | |
| 153-16-B-184005-S | In distribution | |
| 153-16-B-163505-S | In distribution | |
| 153-16-L-166005-S | In distribution | |
| 153-16-B-183010-S | In distribution | |
| 153-16-L-204000-S | In distribution | |
| 153-16-L-163500-S | In distribution | |
| 153-16-L-224005-S | In distribution | |
| 153-16-L-224000-S | In distribution | |
| 153-16-R-220000-S | In distribution | |
| 153-16-B-165000-S | In distribution | |
| 153-16-B-163510-S | In distribution | |
| 153-16-L-185010-S | In distribution | |
| 153-16-L-185005-S | In distribution | |
| 153-16-R-260010-S | In distribution | |
| 153-16-B-163000-S | In distribution | |
| 153-16-L-202505-S | In distribution | |
| 153-16-L-203510-S | In distribution | |
| 153-16-L-203500-S | In distribution | |
| 153-16-L-225510-S | In distribution | |
| 153-16-L-165005-S | In distribution | |
| 153-16-L-166010-S | In distribution | |
| 153-16-L-203000-S | In distribution | |
| 153-16-B-163005-S | In distribution | |
| 153-16-L-164005-S | In distribution | |
| 153-16-L-205500-S | In distribution | |
| 153-16-L-202510-S | In distribution | |
| 153-16-L-165505-S | In distribution | |
| 153-16-L-183505-S | In distribution | |
| 153-16-B-164005-S | In distribution | |
| 153-16-L-226005-S | In distribution | |
| 153-16-L-163505-S | In distribution | |
| 153-16-L-183005-S | In distribution | |
| 153-16-B-163500-S | In distribution | |
| 153-16-B-163010-S | In distribution | |
| 153-16-B-164500-S | In distribution | |
| 153-16-B-183500-S | In distribution | |
| 153-16-L-225500-S | In distribution | |
| 153-16-B-183000-S | In distribution | |
| 153-16-L-204500-S | In distribution | |
| 153-16-L-204005-S | In distribution | |
| 153-16-L-205505-S | In distribution | |
| 153-16-L-162510-S | In distribution | |
| 153-16-R-280010-S | In distribution | |
| 153-16-L-226000-S | In distribution | |
| 153-16-L-222500-S | In distribution | |
| 153-16-L-222505-S | In distribution | |
| 153-16-R-220010-S | In distribution | |
| 153-16-L-223510-S | In distribution | |
| 153-16-L-165510-S | In distribution | |
| 153-16-L-164010-S | In distribution | |
| 153-16-L-223010-S | In distribution | |
| 153-16-L-205010-S | In distribution | |
| 153-16-L-185510-S | In distribution | |
| 153-16-L-184000-S | In distribution | |
| 153-16-R-280005-S | In distribution | |
| 153-16-B-184000-S | In distribution | |
| 153-16-L-225505-S | In distribution | |
| 153-16-R-200000-S | In distribution | |
| 153-16-R-240010-S | In distribution | |
| 153-16-B-185000-S | In distribution | |
| 153-16-L-184500-S | In distribution | |
| 153-16-L-162505-S | In distribution | |
| 153-16-B-164510-S | In distribution | |
| 153-16-L-166000-S | In distribution | |
| 153-16-L-185500-S | In distribution | |
| 153-16-L-204505-S | In distribution | |
| 153-16-L-203505-S | In distribution | |
| 153-16-L-223505-S | In distribution | |
| 153-16-B-182510-S | In distribution | |
| 153-16-L-183500-S | In distribution | |
| 153-16-L-204510-S | In distribution | |
| 153-16-L-164000-S | In distribution | |
| 153-16-L-184510-S | In distribution | |
| 153-16-L-224010-S | In distribution | |
| 153-16-L-183000-S | In distribution | |
| 153-16-L-206010-S | In distribution | |
| 153-16-L-185000-S | In distribution | |
| 153-16-L-185505-S | In distribution | |
| 153-16-B-165010-S | In distribution | |
| 153-16-R-220005-S | In distribution | |
| 153-16-B-183505-S | In distribution | |
| 153-16-L-184010-S | In distribution | |
| 153-16-L-163005-S | In distribution | |
| 153-16-L-164505-S | In distribution | |
| 153-16-L-206005-S | In distribution | |
| 153-16-B-165005-S | In distribution | |
| 153-16-L-226010-S | In distribution | |
| 153-16-L-225010-S | In distribution | |
| 153-16-L-164500-S | In distribution | |
| 153-16-L-203005-S | In distribution | |
| 153-16-L-205510-S | In distribution | |
| 153-16-L-223500-S | In distribution | |
| 153-16-B-184510-S | In distribution | |
| 153-16-B-184505-S | In distribution | |
| 153-16-L-203010-S | In distribution | |
| 153-16-L-184505-S | In distribution | |
| 153-16-L-165500-S | In distribution | |
| 153-16-R-240000-S | In distribution | |
| 153-16-B-162500-S | In distribution | |
| 153-16-L-163010-S | In distribution | |
| 153-16-L-165010-S | In distribution | |
| 153-16-L-162500-S | In distribution | |
| 153-16-L-184005-S | In distribution | |
| 153-16-R-260000-S | In distribution | |
| 153-16-L-205005-S | In distribution | |
| 153-16-R-200010-S | In distribution | |
| 153-16-L-202500-S | In distribution | |
| 153-16-B-183510-S | In distribution | |
| 153-16-L-204010-S | In distribution | |
| 153-16-L-163510-S | In distribution | |
| 153-16-B-184010-S | In distribution | |
| 153-16-L-182505-S | In distribution | |
| 153-16-B-164010-S | In distribution | |
| 153-16-L-164510-S | In distribution | |
| 153-16-L-183010-S | In distribution | |
| 153-16-B-164000-S | In distribution | |
| 153-16-B-185010-S | In distribution | |
| 153-16-R-260005-S | In distribution | |
| 153-16-L-186005-S | In distribution | |
| 153-16-B-164505-S | In distribution | |
| 153-16-B-182500-S | In distribution | |
| 153-16-L-224500-S | In distribution | |
| 153-16-L-182510-S | In distribution | |
| 153-16-B-184500-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Shark Lumbar Spacer System | Choice Spine, LP | 34 |
| Therapak | Therapak, LLC | 33 |
| Octane Straight IR | Choice Spine, LP | 7 |
| Medline | Medline Industries, Inc. | 3 |
| Xpeedy | Cura Diagnostics Inc. | 3 |
| Mdhc | Mdhc Life Technologies (Kunshan) Co., Ltd. | 1 |
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.