Foundation System
Foundation ANT Lumbar Cage - 16MM X 16MM X 26MM - 13 Degree - Aggressive Teeth
7manufacturers in China registered for this device type
336catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Corelink, LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2016-01-21 |
| Record revised | 2020-02-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 5 to 21 mm; length 20 to 60 mm; width 10 to 35 mm; angle 4 to 13 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 840855-08 | Length 55 mm | In distribution |
| 870045-14 | Length 45 mm | In distribution |
| 870045-07 | Width 18 mm | In distribution |
| SAT0713 | Length 26 mm | In distribution |
| 870025-10 | Width 18 mm | In distribution |
| CL0706 | Height 6 mm | In distribution |
| 830850-09 | Height 9 mm | In distribution |
| 830840-08 | Width 18 mm | In distribution |
| 860055-16 | Length 55 mm | In distribution |
| 870035-09 | Width 18 mm | In distribution |
| 860050-07 | Width 16 mm | In distribution |
| 840845-09 | Length 45 mm | In distribution |
| 860060-15 | Length 60 mm | In distribution |
| PLW3213 | Width 12 mm | In distribution |
| 870045-11 | Length 45 mm | In distribution |
| PL3017 | Length 30 mm | In distribution |
| LA1321 | Width 35 mm | In distribution |
| 860035-16 | Length 35 mm | In distribution |
| PLW3015 | Width 12 mm | In distribution |
| PM2618 | Length 26 mm | In distribution |
| 840050-13 | Width 22 mm | In distribution |
| XCL0709 | Angle 7 ° | In distribution |
| SAT1316 | Length 26 mm | In distribution |
| 880030-13 | Height 13 mm | In distribution |
| 840850-15 | Height 15 mm | In distribution |
| 840850-16 | Height 16 mm | In distribution |
| 840055-14 | Width 22 mm | In distribution |
| 840050-15 | Height 15 mm | In distribution |
| PM2615 | Height 15 mm | In distribution |
| MAT1311 | Length 20 mm | In distribution |
| PMW2611 | Height 11 mm | In distribution |
| XAT1317 | Angle 13 ° | In distribution |
| 880035-10 | Height 10 mm | In distribution |
| LAT1317 | Height 17 mm | In distribution |
| LA1314 | Height 14 mm | In distribution |
| 840840-08 | Length 40 mm | In distribution |
| 870055-08 | Length 55 mm | In distribution |
| 860035-09 | Length 35 mm | In distribution |
| 840045-09 | Height 9 mm | In distribution |
| MA0717 | Height 17 mm | In distribution |
| CL0412 | Height 12 mm | In distribution |
| MA1319 | Width 32 mm | In distribution |
| LAT1312 | Length 25 mm | In distribution |
| LCL0408 | Angle 4 ° | In distribution |
| 831255-12 | Height 12 mm | In distribution |
| 830850-10 | Height 10 mm | In distribution |
| 831255-10 | Angle 12 ° | In distribution |
| PMW2614 | Width 12 mm | In distribution |
| 840845-15 | Height 15 mm | In distribution |
| 860060-08 | Height 8 mm | In distribution |
| 840055-11 | Width 22 mm | In distribution |
| LA0720 | Length 25 mm | In distribution |
| SAT0717 | Length 26 mm | In distribution |
| 840855-13 | Width 22 mm | In distribution |
| 870025-15 | Height 15 mm | In distribution |
| MA1309 | Height 9 mm | In distribution |
| 870055-13 | Height 13 mm | In distribution |
| 840840-15 | Height 15 mm | In distribution |
| 860060-13 | Height 13 mm | In distribution |
| 870040-15 | Length 40 mm | In distribution |
| SAT1309 | Height 9 mm | In distribution |
| 841255-12 | Height 12 mm | In distribution |
| 870040-10 | Length 40 mm | In distribution |
| SAT1315 | Width 16 mm | In distribution |
| 830845-16 | Length 45 mm | In distribution |
| PLW3218 | Length 32 mm | In distribution |
| MA0709 | Height 9 mm | In distribution |
| 870050-11 | Length 50 mm | In distribution |
| 880035-09 | Width 22 mm | In distribution |
| 830050-13 | Width 18 mm | In distribution |
| LAT0721 | Angle 7 ° | In distribution |
| 840850-09 | Height 9 mm | In distribution |
| PM2612 | Length 26 mm | In distribution |
| XA0721 | Length 41 mm | In distribution |
| 870030-09 | Height 9 mm | In distribution |
| 870040-13 | Width 18 mm | In distribution |
| LCL0411 | Height 11 mm | In distribution |
| 870035-15 | Height 15 mm | In distribution |
| XA0709 | Height 9 mm | In distribution |
| 860025-15 | Length 25 mm | In distribution |
| 830860-10 | Angle 8 ° | In distribution |
| PLW3018 | Length 30 mm | In distribution |
| CL0709 | Angle 7 ° | In distribution |
| 840850-14 | Height 14 mm | In distribution |
| PMW2617 | Height 17 mm | In distribution |
| SAT0711 | Height 11 mm | In distribution |
| XA1317 | Height 17 mm | In distribution |
| 860045-16 | Width 16 mm | In distribution |
| LA1313 | Height 13 mm | In distribution |
| XA1318 | Length 41 mm | In distribution |
| TL3014 | Height 14 mm | In distribution |
| 840845-13 | Height 13 mm | In distribution |
| 870050-09 | Height 9 mm | In distribution |
| 860050-14 | Length 50 mm | In distribution |
| 830040-08 | Length 40 mm | In distribution |
| 860045-12 | Length 45 mm | In distribution |
| 830855-11 | Length 55 mm | In distribution |
| CL0710 | Height 10 mm | In distribution |
| 840050-09 | Length 50 mm | In distribution |
| 860060-09 | Width 16 mm | In distribution |
| LA0716 | Height 16 mm | In distribution |
| SAT0710 | Angle 7 ° | In distribution |
| 860045-13 | Width 16 mm | In distribution |
| MAT1314 | Length 20 mm | In distribution |
| 840045-12 | Height 12 mm | In distribution |
| PMW2616 | Length 26 mm | In distribution |
| XA1319 | Angle 13 ° | In distribution |
| 870060-10 | Length 60 mm | In distribution |
| CL0410 | Height 10 mm | In distribution |
| 860025-16 | Height 16 mm | In distribution |
| 840060-15 | Height 15 mm | In distribution |
| 870060-07 | Height 7 mm | In distribution |
| TL3016 | Height 16 mm | In distribution |
| 830040-13 | Height 13 mm | In distribution |
| XA0712 | Width 28 mm | In distribution |
| MAT0717 | Length 20 mm | In distribution |
| TL3009 | Height 9 mm | In distribution |
| SA1311 | Length 26 mm | In distribution |
| MA0714 | Height 14 mm | In distribution |
| 830845-10 | Height 10 mm | In distribution |
| MAT0714 | Width 32 mm | In distribution |
| 831250-11 | Width 18 mm | In distribution |
| PMW2615 | Width 12 mm | In distribution |
| 870055-15 | Height 15 mm | In distribution |
| 860040-07 | Length 40 mm | In distribution |
| 830060-15 | Length 60 mm | In distribution |
| 841250-15 | Angle 12 ° | In distribution |
| 870035-14 | Width 18 mm | In distribution |
| 880040-12 | Height 12 mm | In distribution |
| LAT0711 | Length 25 mm | In distribution |
| MAT1313 | Height 13 mm | In distribution |
| 830850-15 | Height 15 mm | In distribution |
| 840860-13 | Angle 8 ° | In distribution |
| LCL0708 | Height 8 mm | In distribution |
| CL0711 | Angle 7 ° | In distribution |
| 870030-07 | Height 7 mm | In distribution |
| LA0713 | Length 25 mm | In distribution |
| MAT0711 | Width 32 mm | In distribution |
| 860035-07 | Length 35 mm | In distribution |
| MAT0713 | Height 13 mm | In distribution |
| MA1310 | Length 20 mm | In distribution |
| TM2513 | Length 25 mm | In distribution |
| 860050-15 | Length 50 mm | In distribution |
| 870030-16 | Length 30 mm | In distribution |
| XA0711 | Angle 7 ° | In distribution |
| 880035-13 | Length 35 mm | In distribution |
| 870050-12 | Length 50 mm | In distribution |
| 870040-16 | Length 40 mm | In distribution |
| XAT1318 | Angle 13 ° | In distribution |
| 870025-12 | Height 12 mm | In distribution |
| 840050-10 | Height 10 mm | In distribution |
| 831255-08 | Height 8 mm | In distribution |
| PMW2618 | Width 12 mm | In distribution |
| LAT0709 | Height 9 mm | In distribution |
| 840045-16 | Height 16 mm | In distribution |
| 860035-11 | Height 11 mm | In distribution |
| 840845-11 | Angle 8 ° | In distribution |
| 880035-16 | Length 35 mm | In distribution |
| MA1312 | Length 20 mm | In distribution |
| 830050-09 | Length 50 mm | In distribution |
| PL3012 | Height 12 mm | In distribution |
| 840855-12 | Height 12 mm | In distribution |
| LCL0712 | Angle 7 ° | In distribution |
| 870025-08 | Width 18 mm | In distribution |
| 840860-10 | Width 22 mm | In distribution |
| 870050-08 | Width 18 mm | In distribution |
| TL3008 | Height 8 mm | In distribution |
| 860050-16 | Width 16 mm | In distribution |
| 840060-09 | Length 60 mm | In distribution |
| XA1315 | Width 28 mm | In distribution |
| 830845-09 | Height 9 mm | In distribution |
| 870035-10 | Length 35 mm | In distribution |
| 830055-09 | Length 55 mm | In distribution |
| 841255-11 | Angle 12 ° | In distribution |
| 831255-09 | Width 18 mm | In distribution |
| PS2215 | Length 22 mm | In distribution |
| LCL0410 | Angle 4 ° | In distribution |
| LAT1316 | Height 16 mm | In distribution |
| 840040-09 | Width 22 mm | In distribution |
| 840055-12 | Width 22 mm | In distribution |
| CL0405 | Angle 4 ° | In distribution |
| 870035-07 | Height 7 mm | In distribution |
| SA0716 | Length 26 mm | In distribution |
| TL3015 | Height 15 mm | In distribution |
| TL3012 | Length 30 mm | In distribution |
| 860035-12 | Height 12 mm | In distribution |
| PLW3215 | Width 12 mm | In distribution |
| 840860-09 | Width 22 mm | In distribution |
| XA0717 | Angle 7 ° | In distribution |
| 860030-16 | Width 16 mm | In distribution |
| 870050-14 | Length 50 mm | In distribution |
| 830855-16 | Height 16 mm | In distribution |
| 830855-08 | Length 55 mm | In distribution |
| 870035-11 | Width 18 mm | In distribution |
| 860055-13 | Width 16 mm | In distribution |
| 830050-11 | Length 50 mm | In distribution |
| 840060-13 | Length 60 mm | In distribution |
| MAT0712 | Height 12 mm | In distribution |
| PLW3011 | Length 30 mm | In distribution |
| SA0714 | Height 14 mm | In distribution |
| 860040-12 | Height 12 mm | In distribution |
| XA1320 | Angle 13 ° | In distribution |
| 830055-11 | Height 11 mm | In distribution |
| 840850-13 | Width 22 mm | In distribution |
| 870060-09 | Height 9 mm | In distribution |
| MAT1315 | Angle 13 ° | In distribution |
| PLW3016 | Width 12 mm | In distribution |
| PMW2610 | Width 12 mm | In distribution |
| SAT0709 | Length 26 mm | In distribution |
| XAT0711 | Length 41 mm | In distribution |
| 880040-08 | Width 22 mm | In distribution |
| 840045-15 | Width 22 mm | In distribution |
| 831250-09 | Length 50 mm | In distribution |
| MA1317 | Height 17 mm | In distribution |
| 840060-11 | Width 22 mm | In distribution |
| 840855-16 | Height 16 mm | In distribution |
| 860055-09 | Width 16 mm | In distribution |
| 860025-07 | Length 25 mm | In distribution |
| SA1316 | Height 16 mm | In distribution |
| MAT0716 | Height 16 mm | In distribution |
| PLW3212 | Height 12 mm | In distribution |
| 860040-08 | Width 16 mm | In distribution |
| 880040-07 | Height 7 mm | In distribution |
| SAT1319 | Width 16 mm | In distribution |
| 860040-16 | Length 40 mm | In distribution |
| 840860-08 | Angle 8 ° | In distribution |
| 860060-10 | Width 16 mm | In distribution |
| 860025-13 | Height 13 mm | In distribution |
| 860040-15 | Height 15 mm | In distribution |
| LCL0412 | Angle 4 ° | In distribution |
| XAT0718 | Angle 7 ° | In distribution |
| 841255-13 | Length 55 mm | In distribution |
| SAT1310 | Width 16 mm | In distribution |
| 880035-15 | Height 15 mm | In distribution |
| LA1318 | Height 18 mm | In distribution |
| 840055-13 | Height 13 mm | In distribution |
| 831250-12 | Width 18 mm | In distribution |
| 880040-11 | Height 11 mm | In distribution |
| 870055-12 | Width 18 mm | In distribution |
| 830845-14 | Angle 8 ° | In distribution |
| 880030-15 | Length 30 mm | In distribution |
| SA1315 | Angle 13 ° | In distribution |
| MA0715 | Height 15 mm | In distribution |
| 840060-10 | Length 60 mm | In distribution |
| 860030-06 | Length 30 mm | In distribution |
| 860050-09 | Length 50 mm | In distribution |
| 840045-11 | Width 22 mm | In distribution |
| XA1316 | Length 41 mm | In distribution |
| MAT1317 | Height 17 mm | In distribution |
| 860040-13 | Width 16 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230329 | 2023-06-06 |
| K162496 | 2017-05-04 |
| K150847 | 2015-08-13 |
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.