Ascend
16mm CORE EXP 21-29mm LAT EP 18x45mm 0°
3manufacturers in China registered for this device type
555catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232173 |
| Record published | 2025-04-03 |
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 | Width 12 to 22 mm; length 20 to 60 mm; angle 5 to 10 °; outer diameter 12 to 28 mm; height 14 to 105 mm; depth 12 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 157-PRO-16L-185505-S | Width 18 mm | In distribution |
| 157-PRO-12K-143005-S | Angle 5 ° | In distribution |
| 157-PRO-16K-163505-S | Angle 5 ° | In distribution |
| 157-PRO-12L-203010-S | Length 30 mm | In distribution |
| 157-PRO-12B-163507-S | Length 35 mm | In distribution |
| 157-PRO-16B-184500-S | Length 45 mm | In distribution |
| 157-PRO-12K-142507-S | Length 25 mm | In distribution |
| 157-PRO-12B-184005-S | Length 40 mm | In distribution |
| 157-PRO-12B-122507-S | Width 12 mm | In distribution |
| 157-PRO-12L-223500-S | Length 35 mm | In distribution |
| 157-PRO-16L-162505-S | Length 25 mm | In distribution |
| 157-PRO-12L-226005-S | Length 60 mm | In distribution |
| 157-PRO-12L-165505-S | Width 16 mm | In distribution |
| 157-PRO-12L-202510-S | Width 20 mm | In distribution |
| 157-PRO-16B-163505-S | Length 35 mm | In distribution |
| 157-PRO-12B-185007-S | Width 18 mm | In distribution |
| 157-PRO-16K-185010-S | Width 18 mm | In distribution |
| 157-PRO-16K-182505-S | Width 18 mm | In distribution |
| 157-PRO-12K-144505-S | Width 14 mm | In distribution |
| 157-PRO-12K-184507-S | Width 18 mm | In distribution |
| 157-PRO-12K-145007-S | Angle 7 ° | In distribution |
| 157-PRO-16L-164005-S | Length 40 mm | In distribution |
| 157-PRO-16K-184005-S | Angle 5 ° | In distribution |
| 157-PRO-12L-186005-S | Angle 5 ° | In distribution |
| 157-PRO-16R-280010-S | Outer Diameter 28 mm | In distribution |
| 160-12-410-50 | In distribution | |
| 157-PRO-12L-224000-S | Width 22 mm | In distribution |
| 157-PRO-12L-225510-S | Angle 10 ° | In distribution |
| 157-PRO-12K-183507-S | Length 35 mm | In distribution |
| 157-PRO-12L-162500-S | Length 25 mm | In distribution |
| 157-PRO-12L-224005-S | Length 40 mm | In distribution |
| 153-16-R-180005-S | In distribution | |
| 102123-L-184505 | In distribution | |
| 157-PRO-16L-165505-S | Length 55 mm | In distribution |
| 157-PRO-12K-163005-S | Angle 5 ° | In distribution |
| 157-2-16-18 | Height 18 mm | In distribution |
| 157-PRO-12B-123000-S | Width 12 mm | In distribution |
| 157-PRO-12L-204000-S | Length 40 mm | In distribution |
| 157-PRO-12L-206005-S | Width 20 mm | In distribution |
| 157-PRO-12L-183505-S | Angle 5 ° | In distribution |
| 157-PRO-12R-280007-S | Angle 7 ° | In distribution |
| 157-PRO-12L-163510-S | Length 35 mm | In distribution |
| 160-12-410-35 | In distribution | |
| 157-PRO-12B-144000-S | Width 14 mm | In distribution |
| 157-PRO-16B-183505-S | Length 35 mm | In distribution |
| 157-PRO-12B-162007-S | Length 20 mm | In distribution |
| 157-PRO-16B-183500-S | Width 18 mm | In distribution |
| 157-PRO-16R-180010-S | Angle 10 ° | In distribution |
| 157-PRO-16L-185500-S | Length 55 mm | In distribution |
| 157-PRO-16K-185005-S | Width 18 mm | In distribution |
| 159-1-12-140007 | Height 19 mm | In distribution |
| 157-PRO-16L-202510-S | Width 20 mm | In distribution |
| 157-PRO-12B-163005-S | Length 30 mm | In distribution |
| 157-PRO-12K-183510-S | Angle 10 ° | In distribution |
| 157-PRO-12B-122500-S | Length 25 mm | In distribution |
| 157-PRO-12K-184510-S | Length 45 mm | In distribution |
| 157-PRO-16L-204000-S | Width 20 mm | In distribution |
| 157-PRO-16K-163005-S | Width 16 mm | In distribution |
| 157-PRO-12K-185010-S | Width 18 mm | In distribution |
| 157-PRO-12L-225005-S | Width 22 mm | In distribution |
| 157-PRO-16R-240005-S | Outer Diameter 24 mm | In distribution |
| 157-PRO-12L-183000-S | Length 30 mm | In distribution |
| 157-PRO-12L-203005-S | Length 30 mm | In distribution |
| 157-PRO-12K-183505-S | Width 18 mm | In distribution |
| 157-PRO-12B-183010-S | Width 18 mm | In distribution |
| 157-PRO-16L-166010-S | Angle 10 ° | In distribution |
| 157-PRO-12B-144007-S | Length 40 mm | In distribution |
| 157-PRO-16L-166005-S | Angle 5 ° | In distribution |
| 157-PRO-16B-183000-S | Width 18 mm | In distribution |
| 157-PRO-12K-184007-S | Length 40 mm | In distribution |
| 157-PRO-12L-165500-S | Length 55 mm | In distribution |
| 153-0-16-40 | In distribution | |
| 157-PRO-16R-260000-S | Outer Diameter 26 mm | In distribution |
| 157-PRO-12B-164507-S | Width 16 mm | In distribution |
| 157-PRO-16B-182510-S | Angle 10 ° | In distribution |
| 157-PRO-12B-123007-S | Length 30 mm | In distribution |
| 157-PRO-12L-184505-S | Width 18 mm | In distribution |
| 157-PRO-12K-125007-S | Length 50 mm | In distribution |
| 157-PRO-12B-122000-S | Width 12 mm | In distribution |
| 157-PRO-16K-165005-S | Length 50 mm | In distribution |
| 157-PRO-12K-142505-S | Angle 5 ° | In distribution |
| 157-PRO-12B-164510-S | Width 16 mm | In distribution |
| 157-PRO-16B-182500-S | Length 25 mm | In distribution |
| 157-PRO-12K-144007-S | Angle 7 ° | In distribution |
| 157-PRO-12B-163000-S | Length 30 mm | In distribution |
| 157-PRO-12L-205000-S | Width 20 mm | In distribution |
| 157-PRO-12B-162507-S | Angle 7 ° | In distribution |
| 157-PRO-12L-163505-S | Width 16 mm | In distribution |
| 153-0-16-70 | In distribution | |
| 157-PRO-12L-185010-S | Length 50 mm | In distribution |
| 159-1-12-1700MO | Height 23 mm | In distribution |
| 157-PRO-16B-164500-S | Width 16 mm | In distribution |
| 157-PRO-12B-122007-S | Width 12 mm | In distribution |
| 157-PRO-12R-260007-S | Angle 7 ° | In distribution |
| 157-PRO-16L-164000-S | Width 16 mm | In distribution |
| 157-PRO-12B-184505-S | Width 18 mm | In distribution |
| 157-PRO-16R-280000-S | Outer Diameter 28 mm | In distribution |
| 157-PRO-12B-183000-S | Length 30 mm | In distribution |
| 157-PRO-16L-163005-S | Length 30 mm | In distribution |
| 157-PRO-12B-143507-S | Length 35 mm | In distribution |
| 157-PRO-16L-183500-S | Width 18 mm | In distribution |
| 157-PRO-12K-144005-S | Angle 5 ° | In distribution |
| 157-PRO-12K-122010-S | Length 20 mm | In distribution |
| 157-PRO-12B-144507-S | Width 14 mm | In distribution |
| 157-0-16-50 | Height 50 mm | In distribution |
| 157-PRO-12L-186000-S | Length 60 mm | In distribution |
| 157-PRO-12B-163505-S | Length 35 mm | In distribution |
| 157-PRO-12L-163010-S | Width 16 mm | In distribution |
| 157-PRO-16L-163000-S | Length 30 mm | In distribution |
| 157-PRO-12B-182007-S | Length 20 mm | In distribution |
| 157-PRO-16L-184505-S | Width 18 mm | In distribution |
| 157-PRO-12B-125010-S | Length 50 mm | In distribution |
| 157-PRO-16L-184510-S | Length 45 mm | In distribution |
| 157-PRO-12K-164507-S | Width 16 mm | In distribution |
| 157-PRO-12B-162005-S | Angle 5 ° | In distribution |
| 157-PRO-16L-166000-S | Width 16 mm | In distribution |
| 157-PRO-16L-225505-S | Angle 5 ° | In distribution |
| 157-PRO-12R-280010-S | Outer Diameter 28 mm | In distribution |
| 157-PRO-16L-165000-S | Length 50 mm | In distribution |
| 157-PRO-16B-163510-S | Angle 10 ° | In distribution |
| 157-PRO-12R-240005-S | Angle 5 ° | In distribution |
| 157-PRO-12B-122005-S | Length 20 mm | In distribution |
| 157-PRO-16R-200005-S | Outer Diameter 20 mm | In distribution |
| 157-PRO-12R-140005-S | Angle 5 ° | In distribution |
| 157-PRO-12K-162005-S | Length 20 mm | In distribution |
| 157-PRO-12K-164005-S | Length 40 mm | In distribution |
| 157-PRO-16L-205005-S | Length 50 mm | In distribution |
| 157-PRO-12B-183007-S | Length 30 mm | In distribution |
| 157-PRO-16L-202500-S | Width 20 mm | In distribution |
| 157-PRO-12B-124010-S | Width 12 mm | In distribution |
| 157-PRO-12B-183500-S | Length 35 mm | In distribution |
| 157-PRO-12L-166010-S | Angle 10 ° | In distribution |
| 154-16-100 | In distribution | |
| 157-PRO-12B-122510-S | Angle 10 ° | In distribution |
| 157-PRO-16L-184500-S | Length 45 mm | In distribution |
| 159-0-12-70 | Height 105 mm | In distribution |
| 157-PRO-12B-122010-S | Width 12 mm | In distribution |
| 157-PRO-12B-164505-S | Length 45 mm | In distribution |
| 154-16-110 | In distribution | |
| 157-PRO-16L-164510-S | Length 45 mm | In distribution |
| 157-PRO-12L-163500-S | Length 35 mm | In distribution |
| 157-PRO-16L-183510-S | Length 35 mm | In distribution |
| 153-0-16-26 | In distribution | |
| 157-PRO-16L-203505-S | Width 20 mm | In distribution |
| 102123-B-163005 | In distribution | |
| 157-PRO-12B-142500-S | Length 25 mm | In distribution |
| 157-PRO-12L-204500-S | Width 20 mm | In distribution |
| 157-PRO-16L-203010-S | Length 30 mm | In distribution |
| 157-PRO-16K-164010-S | Angle 10 ° | In distribution |
| 157-PRO-12L-164500-S | Length 45 mm | In distribution |
| 157-PRO-16L-223505-S | Width 22 mm | In distribution |
| 157-PRO-12K-123010-S | Length 30 mm | In distribution |
| 159-1-12-140710 | Height 14 mm | In distribution |
| 157-PRO-12L-183510-S | Angle 10 ° | In distribution |
| 157-PRO-12L-222505-S | Angle 5 ° | In distribution |
| 157-PRO-12K-182005-S | Length 20 mm | In distribution |
| 157-PRO-12L-202505-S | Width 20 mm | In distribution |
| 157-PRO-12B-164010-S | Width 16 mm | In distribution |
| 157-PRO-12L-185510-S | Width 18 mm | In distribution |
| 157-PRO-12B-165000-S | Length 50 mm | In distribution |
| 157-PRO-16L-186005-S | Length 60 mm | In distribution |
| 157-PRO-12B-124005-S | Length 40 mm | In distribution |
| 157-PRO-12K-124505-S | Length 45 mm | In distribution |
| 157-PRO-12L-164000-S | Width 16 mm | In distribution |
| 157-PRO-12R-160000-S | Outer Diameter 16 mm | In distribution |
| 160-12-410-23 | In distribution | |
| 157-PRO-16R-220000-S | Outer Diameter 22 mm | In distribution |
| 157-PRO-12L-185000-S | Length 50 mm | In distribution |
| 157-PRO-12B-144505-S | Length 45 mm | In distribution |
| 157-PRO-16L-225005-S | Length 50 mm | In distribution |
| 157-PRO-12K-162510-S | Angle 10 ° | In distribution |
| 157-PRO-16L-223005-S | Width 22 mm | In distribution |
| 157-PRO-16L-165005-S | Angle 5 ° | In distribution |
| 157-PRO-16L-224010-S | Length 40 mm | In distribution |
| 157-PRO-16L-163505-S | Length 35 mm | In distribution |
| 157-PRO-12K-183005-S | Length 30 mm | In distribution |
| 157-PRO-12K-162505-S | Length 25 mm | In distribution |
| 157-PRO-12B-164007-S | Angle 7 ° | In distribution |
| 157-PRO-12B-182010-S | Angle 10 ° | In distribution |
| 157-PRO-12L-223510-S | Length 35 mm | In distribution |
| 157-PRO-16K-182510-S | Angle 10 ° | In distribution |
| 153-2-16-22 | In distribution | |
| 157-PRO-12B-162510-S | Angle 10 ° | In distribution |
| 157-PRO-16L-162500-S | Length 25 mm | In distribution |
| 157-PRO-12B-164000-S | Length 40 mm | In distribution |
| 157-PRO-12L-164505-S | Width 16 mm | In distribution |
| 157-PRO-12B-162500-S | Length 25 mm | In distribution |
| 157-PRO-12B-165007-S | Length 50 mm | In distribution |
| 157-PRO-12L-222500-S | Width 22 mm | In distribution |
| 157-PRO-16L-226010-S | Length 60 mm | In distribution |
| 157-PRO-12B-144500-S | Length 45 mm | In distribution |
| 157-PRO-12B-144010-S | Angle 10 ° | In distribution |
| 157-PRO-12L-184500-S | Length 45 mm | In distribution |
| 157-PRO-12L-185005-S | Length 50 mm | In distribution |
| 157-PRO-16L-164505-S | Length 45 mm | In distribution |
| 157-PRO-16R-240010-S | Outer Diameter 24 mm | In distribution |
| 157-PRO-12R-180000-S | Outer Diameter 18 mm | In distribution |
| 157-PRO-12B-123005-S | Length 30 mm | In distribution |
| 157-PRO-12T-181400-S | Depth 14 mm | In distribution |
| 153-2-16-26 | In distribution | |
| 157-PRO-16L-202505-S | Length 25 mm | In distribution |
| 157-PRO-16L-225500-S | Width 22 mm | In distribution |
| 102123-L-184500 | In distribution | |
| 157-PRO-12L-203505-S | Length 35 mm | In distribution |
| 157-PRO-12L-205010-S | Length 50 mm | In distribution |
| 157-PRO-12K-163505-S | Angle 5 ° | In distribution |
| 157-PRO-12K-122007-S | Length 20 mm | In distribution |
| 159-1-12-140000 | Height 19 mm | In distribution |
| 157-PRO-12K-143507-S | Length 35 mm | In distribution |
| 157-PRO-12B-123010-S | Width 12 mm | In distribution |
| 157-PRO-12B-182005-S | Angle 5 ° | In distribution |
| 157-PRO-12B-125005-S | Length 50 mm | In distribution |
| 157-PRO-12B-162505-S | Length 25 mm | In distribution |
| 157-PRO-12K-145010-S | Width 14 mm | In distribution |
| 157-PRO-16R-220010-S | Angle 10 ° | In distribution |
| 157-PRO-12K-142510-S | Angle 10 ° | In distribution |
| 157-PRO-12K-124507-S | Length 45 mm | In distribution |
| 157-PRO-12K-184505-S | Length 45 mm | In distribution |
| 157-PRO-12R-220007-S | Outer Diameter 22 mm | In distribution |
| 157-PRO-16R-160000-S | Outer Diameter 16 mm | In distribution |
| 157-PRO-12K-122507-S | Length 25 mm | In distribution |
| 157-PRO-12T-181610-S | Depth 16 mm | In distribution |
| 158-420-R-1822 | In distribution | |
| 157-PRO-12T-141207-S | Width 14 mm | In distribution |
| 158-420-L-1822 | In distribution | |
| 157-PRO-12L-204005-S | Length 40 mm | In distribution |
| 157-PRO-12B-184010-S | Width 18 mm | In distribution |
| 157-PRO-12L-184510-S | Length 45 mm | In distribution |
| 157-PRO-12K-182510-S | Width 18 mm | In distribution |
| 157-PRO-12B-184500-S | Length 45 mm | In distribution |
| 153-16-R-160000-S | In distribution | |
| 157-PRO-16L-225000-S | Width 22 mm | In distribution |
| 157-PRO-16L-223000-S | Width 22 mm | In distribution |
| 157-PRO-12B-162010-S | Angle 10 ° | In distribution |
| 157-PRO-12R-240010-S | Outer Diameter 24 mm | In distribution |
| 157-PRO-16K-184505-S | Angle 5 ° | In distribution |
| 157-PRO-16L-165010-S | Width 16 mm | In distribution |
| 157-PRO-16B-164005-S | Width 16 mm | In distribution |
| 157-PRO-16L-204500-S | Length 45 mm | In distribution |
| 157-PRO-12L-163000-S | Length 30 mm | In distribution |
| 157-PRO-16L-162510-S | Length 25 mm | In distribution |
| 157-PRO-12R-220005-S | Outer Diameter 22 mm | In distribution |
| 157-PRO-12L-204510-S | Length 45 mm | In distribution |
| 157-PRO-12B-143510-S | Length 35 mm | In distribution |
| 157-PRO-12B-142007-S | Angle 7 ° | In distribution |
| 157-PRO-12K-182010-S | Length 20 mm | In distribution |
| 157-PRO-12B-122505-S | Length 25 mm | In distribution |
| 157-PRO-12K-124007-S | Angle 7 ° | In distribution |
| 157-PRO-12L-184010-S | Width 18 mm | In distribution |
| 157-PRO-12B-165010-S | Angle 10 ° | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
| Novel Spinal Spacer System | Alphatec Spine, Inc. | 340 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232173 | 2023-10-06 |
| K080699 | 2008-05-21 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-08-16 | Not classified | Process control | Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the follo | 3 units | 2009-01-12 |
| 2007-08-16 | Not classified | Process control | Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. They were incorrectly laser marked with the wrong part numbers and sizes. Two lots were mixed from the follo | 4 units | 2009-01-12 |
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.