Cascadia™ Interbody System
AN Lordotic-Oblique Interbody, Size 8.5x28x13 mm, 12°
7manufacturers in China registered for this device type
823catalogue numbers in this listing
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 | VB Spine LLC |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K150481 |
| Record published | 2016-09-02 |
| Record revised | 2026-04-20 (version 9) |
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 |
| Sizes | Height 4 to 24 mm; length 11 to 65 mm; width 8.5 to 26 mm; angle 6 to 30 ° |
| Distribution end date | 2024-07-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6101-2103217NC-G2 | Length 32 mm | In distribution |
| 6101-2852814NC-G2 | Length 28 mm | In distribution |
| 402-90620 | Width 18 mm | In distribution |
| 6101-2103209NC-G2 | Length 32 mm | In distribution |
| 6101-2853211NT6-G2 | Width 8.5 mm | In distribution |
| 6101-2111611HP-G2 | Height 11 mm | In distribution |
| 6101-2123212NC-G2 | Length 28 mm | In distribution |
| 6101-2122005HL7-G2 | Width 20 mm | In distribution |
| 6101-2852406NL18-G2 | Width 8.5 mm | In distribution |
| 6101-2852817NC-G2 | Length 28 mm | In distribution |
| 402-90349 | Height 6 mm | In distribution |
| 6101-2131612CC-G2 | CONVEX | In distribution |
| 6101-2131607CC-G2 | Width 16 mm | In distribution |
| 6101-2265012LL8-G2 | Height 12 mm | In distribution |
| 6101-2123210NC-G2 | Width 12 mm | In distribution |
| 6101-2186012LP-G2 | Width 18 mm | In distribution |
| 6101-2185516LL8-G2 | Angle 8 ° | In distribution |
| 6101-2103207NT6-G2 | Length 32 mm | In distribution |
| 6101-2162007CC-G2 | Height 7 mm | In distribution |
| 6101-2121813HP-G2 | Width 18 mm | In distribution |
| 402-90350 | Angle 12 ° | In distribution |
| SP-2261-39 | Height 13 mm | In distribution |
| SP-4007-03 | Length 12 mm | In distribution |
| 402-90552 | In distribution | |
| 6101-2102814NT6-G2 | Length 28 mm | In distribution |
| 6101-2121811HP-G2 | Length 12.5 mm | In distribution |
| SP-2260-52 | Width 14 mm | In distribution |
| 6101-2224008LL12-G2 | Length 40 mm | In distribution |
| SP-2437-38 | Width 14 mm | In distribution |
| SP-2261-69 | Width 16 mm | In distribution |
| SP-2437-55 | Angle 25 ° | In distribution |
| 402-90410 | Height 12 mm | In distribution |
| 402-90421 | Angle 15 ° | In distribution |
| 6101-2852406NL12-G2 | Height 6 mm | In distribution |
| SP-2261-46 | Height 12 mm | In distribution |
| 6101-2853206NT18-G2 | Height 6 mm | In distribution |
| 402-90622 | Height 9 mm | In distribution |
| 6101-2103608TL7-G2 | Length 36 mm | In distribution |
| 6101-2123207TL7-G2 | Width 12 mm | In distribution |
| SP-2261-24 | Height 7 mm | In distribution |
| 6101-2102809NT18-G2 | Angle 18 ° | In distribution |
| 6101-2185020LP-G2 | Length 50 mm | In distribution |
| 402-90631 | Height 7 mm | In distribution |
| 6101-2141805CL7-G2 | Height 5 mm | In distribution |
| 6101-2122806NC-G2 | CONVEX | In distribution |
| 6101-2102816TL7-G2 | Angle 7 ° | In distribution |
| 6101-2852409NL12-G2 | Length 24 mm | In distribution |
| 6101-2122015HP-G2 | Length 12.5 mm | In distribution |
| 6101-2122812NC-G2 | Length 28 mm | In distribution |
| 6101-2224507LL12-G2 | Width 22 mm | In distribution |
| 6101-2103613TL7-G2 | Angle 7 ° | In distribution |
| 6101-2123615TL7-G2 | Width 12 mm | In distribution |
| 6101-2186010LP-G2 | Width 18 mm | In distribution |
| 6101-2111605HL7-G2 | Height 5 mm | In distribution |
| 6101-2102804NT6-G2 | Width 10 mm | In distribution |
| 6101-2102809NT6-G2 | Height 9 mm | In distribution |
| 6101-2103606TL7-G2 | Height 6 mm | In distribution |
| 6101-2121811HL7-G2 | Width 18 mm | In distribution |
| 6101-2141809CC-G2 | Width 18 mm | In distribution |
| 6101-2123207NC-G2 | Width 12 mm | In distribution |
| 402-90607 | Height 5 mm | In distribution |
| 6101-2225511LL12-G2 | Angle 12 ° | In distribution |
| 402-90616 | Length 11.5 mm | In distribution |
| 6101-2141812CL12-G2 | Angle 12 ° | In distribution |
| 6101-2186014LP-G2 | Width 18 mm | In distribution |
| 6101-2852217NC-G2 | Height 17 mm | In distribution |
| 6101-2102811NT18-G2 | Length 28 mm | In distribution |
| 402-90587 | In distribution | |
| SP-2261-50 | Length 13 mm | In distribution |
| 6101-2184510LL8-G2 | Height 10 mm | In distribution |
| SP-2260-28 | Height 11 mm | In distribution |
| SP-2261-41 | Height 15 mm | In distribution |
| 6101-2122815TL7-G2 | Length 28 mm | In distribution |
| 7908-41F20R | Height 20 mm | In distribution |
| 6101-2121412CP-G2 | Width 14 mm | In distribution |
| SP-2261-49 | Height 15 mm | In distribution |
| PRO-1238-03 | Width 14 mm | In distribution |
| 6101-2224520LL12-G2 | Height 20 mm | In distribution |
| 6101-2852411NL12-G2 | Length 24 mm | In distribution |
| 6101-2121409CP-G2 | Width 14 mm | In distribution |
| 402-90608 | Length 11.5 mm | In distribution |
| 7908-42F243 | Height 24 mm | In distribution |
| 6101-2224016L28-G2 | Width 22 mm | In distribution |
| 6101-2184510LP-G2 | Length 45 mm | In distribution |
| 402-90340 | Width 14 mm | In distribution |
| 6101-2121412CL12-G2 | Height 12 mm | In distribution |
| 6101-2852813NT12-G2 | Length 28 mm | In distribution |
| 402-90624 | Height 11 mm | In distribution |
| 6101-2162009CC-G2 | Length 16 mm | In distribution |
| 6101-2122009HL7-G2 | Angle 7 ° | In distribution |
| 6101-2122812TL7-G2 | Width 12 mm | In distribution |
| 6101-2143214NC-G2 | Length 32 mm | In distribution |
| 6101-90116 | Width 18 mm | In distribution |
| 6101-2102815NT6-G2 | Width 10 mm | In distribution |
| 6101-2122816NC-G2 | Height 16 mm | In distribution |
| SP-2260-53 | Height 9 mm | In distribution |
| 6101-2224508LL15-G2 | Height 8 mm | In distribution |
| 6101-2225020L28-G2 | Width 22 mm | In distribution |
| 6101-2265508LL8-G2 | Length 55 mm | In distribution |
| 402-90551 | In distribution | |
| 402-90388 | Length 12 mm | In distribution |
| 6101-2852807NC-G2 | Height 7 mm | In distribution |
| 402-90391 | Angle 30 ° | In distribution |
| 6101-2184016LL8-G2 | Width 18 mm | In distribution |
| 6101-2265512LL8-G2 | Length 55 mm | In distribution |
| 402-90387 | Height 10 mm | In distribution |
| SP-2261-20 | Width 16 mm | In distribution |
| 6101-2184015LP-G2 | Length 40 mm | In distribution |
| SP-2261-58 | Length 13 mm | In distribution |
| 6101-2102809NT12-G2 | Width 10 mm | In distribution |
| 6101-2185018LL8-G2 | Angle 8 ° | In distribution |
| 6101-90082 | Height 9 mm | In distribution |
| 6101-2852814NT6-G2 | Width 8.5 mm | In distribution |
| 6101-2184008LL8-G2 | Length 40 mm | In distribution |
| SP-2260-64 | Height 13 mm | In distribution |
| 6101-2103215NT6-G2 | Length 32 mm | In distribution |
| 6101-2852212NC-G2 | Length 22 mm | In distribution |
| 6101-2103214NT6-G2 | Width 10 mm | In distribution |
| 6101-2853209NC-G2 | CONVEX | In distribution |
| 6101-2103212NT6-G2 | Angle 6 ° | In distribution |
| 6101-2852407NL12-G2 | Angle 12 ° | In distribution |
| 6101-2123607TL7-G2 | Width 12 mm | In distribution |
| 6101-2121407CL12-G2 | Angle 12 ° | In distribution |
| 6101-2102805NT12-G2 | Width 10 mm | In distribution |
| 6101-2184009LP-G2 | Length 40 mm | In distribution |
| 402-90554 | In distribution | |
| 6101-2141808CL7-G2 | Length 14 mm | In distribution |
| 6101-2121407CP-G2 | Width 14 mm | In distribution |
| SP-2260-15 | Height 8 mm | In distribution |
| 6101-2224513LL12-G2 | Angle 12 ° | In distribution |
| 6101-2225018LL12-G2 | Height 18 mm | In distribution |
| 402-90363 | Angle 15 ° | In distribution |
| 6101-2131607CL7-G2 | Width 16 mm | In distribution |
| 402-90547 | In distribution | |
| SP-2260-47 | Length 12 mm | In distribution |
| 6101-2186014LL8-G2 | Width 18 mm | In distribution |
| 6101-2111607HL7-G2 | Height 7 mm | In distribution |
| 6101-2853210NT6-G2 | Angle 6 ° | In distribution |
| SP-2261-08 | Length 13 mm | In distribution |
| 6101-2224012L22-G2 | Angle 22 ° | In distribution |
| 6101-2186007LL8-G2 | Length 60 mm | In distribution |
| 6101-2225017LL12-G2 | Angle 12 ° | In distribution |
| 6101-2121814HP-G2 | Width 18 mm | In distribution |
| 402-90544 | In distribution | |
| 402-90588 | In distribution | |
| SP-2260-10 | Length 12 mm | In distribution |
| 6101-2185009LP-G2 | Height 9 mm | In distribution |
| 6101-2224018LL12-G2 | Angle 12 ° | In distribution |
| 6101-2141807CL7-G2 | Angle 7 ° | In distribution |
| 6101-2123214TL7-G2 | Width 12 mm | In distribution |
| 6101-2225016L28-G2 | Height 16 mm | In distribution |
| 6101-2103209NT6-G2 | Length 32 mm | In distribution |
| 6101-2103208NT12-G2 | Angle 12 ° | In distribution |
| 6101-2224519LL12-G2 | Angle 12 ° | In distribution |
| 6101-2111614HL7-G2 | Height 14 mm | In distribution |
| 6101-2264512LL8-G2 | Width 26 mm | In distribution |
| 6101-2103206NT12-G2 | Angle 12 ° | In distribution |
| 402-90628 | Length 12.5 mm | In distribution |
| 6101-2186009LP-G2 | Length 60 mm | In distribution |
| SP-4007-07 | Width 14 mm | In distribution |
| 6101-2184512LP-G2 | Length 45 mm | In distribution |
| 6101-2266010LL8-G2 | Angle 8 ° | In distribution |
| SP-2261-56 | Angle 25 ° | In distribution |
| 6101-2102807NT12-G2 | Angle 12 ° | In distribution |
| 6101-2852816NC-G2 | CONVEX | In distribution |
| 402-90559 | In distribution | |
| 6101-2122814NC-G2 | CONVEX | In distribution |
| 6101-2121410CP-G2 | Length 12 mm | In distribution |
| 6101-2141807CC-G2 | Height 7 mm | In distribution |
| 402-90416 | Width 16 mm | In distribution |
| 6101-2852210NC-G2 | CONVEX | In distribution |
| 6101-2121410CL7-G2 | Width 14 mm | In distribution |
| 402-90605 | In distribution | |
| 6101-2121813HL7-G2 | Length 12.5 mm | In distribution |
| 6101-2186011LL8-G2 | Angle 8 ° | In distribution |
| SP-2260-68 | Height 7 mm | In distribution |
| 402-90578 | In distribution | |
| 6101-2123613TL7-G2 | Height 13 mm | In distribution |
| 6101-2224511LL12-G2 | Width 22 mm | In distribution |
| 6101-2226014LL15-G2 | Angle 15 ° | In distribution |
| 6101-2102812NT12-G2 | Height 12 mm | In distribution |
| 6101-2852404NL12-G2 | Angle 12 ° | In distribution |
| PRO-1238-16 | Height 11 mm | In distribution |
| 402-90574 | In distribution | |
| 6101-2184515LP-G2 | Height 15 mm | In distribution |
| 6101-2111607HP-G2 | Width 16 mm | In distribution |
| 6101-2123213TL7-G2 | Angle 7 ° | In distribution |
| 6101-2186020LP-G2 | Width 18 mm | In distribution |
| 6101-2186010LL8-G2 | Width 18 mm | In distribution |
| 6101-2186008LP-G2 | Length 60 mm | In distribution |
| 402-90625 | Height 12 mm | In distribution |
| 6101-2162010CC-G2 | Height 10 mm | In distribution |
| 6101-2226016LL15-G2 | Angle 15 ° | In distribution |
| 6101-2853205NT18-G2 | Length 32 mm | In distribution |
| 6101-2852213NC-G2 | Length 22 mm | In distribution |
| 6101-2226007LL12-G2 | Length 60 mm | In distribution |
| 6101-2185019LP-G2 | Height 19 mm | In distribution |
| 6101-2226012LL15-G2 | Length 60 mm | In distribution |
| SP-4007-04 | Length 12 mm | In distribution |
| 6101-2123606TL7-G2 | Length 36 mm | In distribution |
| 402-90368 | Angle 15 ° | In distribution |
| 402-90404 | Height 6 mm | In distribution |
| 6101-2224512LL15-G2 | Length 45 mm | In distribution |
| 6101-2185517LP-G2 | Width 18 mm | In distribution |
| 6101-2103205NT18-G2 | Angle 18 ° | In distribution |
| 6101-2102812NT6-G2 | Width 10 mm | In distribution |
| 6101-2852214NC-G2 | Height 14 mm | In distribution |
| 402-90524 | Convex | In distribution |
| 6101-2131612CL12-G2 | Width 16 mm | In distribution |
| 402-90420 | Width 16 mm | In distribution |
| 402-90366 | Height 13 mm | In distribution |
| 6101-2123215TL7-G2 | Width 12 mm | In distribution |
| 402-90365 | Height 12 mm | In distribution |
| 6101-2185513LP-G2 | Height 13 mm | In distribution |
| SP-2260-09 | Height 13 mm | In distribution |
| 6101-2141808CL12-G2 | Width 18 mm | In distribution |
| SP-2260-24 | Length 12 mm | In distribution |
| 6101-2102811NT6-G2 | Angle 6 ° | In distribution |
| 6101-2225014LL12-G2 | Length 50 mm | In distribution |
| 6101-2103206NT18-G2 | Length 32 mm | In distribution |
| 6101-2103607TL7-G2 | Angle 7 ° | In distribution |
| 6101-2162008CL7-G2 | Angle 7 ° | In distribution |
| 402-90423 | Angle 20 ° | In distribution |
| 6101-2131612CL15-G2 | Angle 15 ° | In distribution |
| 6101-2184519LL8-G2 | Width 18 mm | In distribution |
| 402-90353 | Angle 12 ° | In distribution |
| 402-90354 | Height 11 mm | In distribution |
| 402-90381 | Angle 25 ° | In distribution |
| PRO-1238-04 | Width 14 mm | In distribution |
| 6101-2852410NL18-G2 | Height 10 mm | In distribution |
| 6101-2102806NT6-G2 | Width 10 mm | In distribution |
| 6101-2852809NT18-G2 | Width 8.5 mm | In distribution |
| 6101-2103214NC-G2 | Height 14 mm | In distribution |
| 6101-2162006CL7-G2 | Angle 7 ° | In distribution |
| 6101-2103207NT12-G2 | Angle 12 ° | In distribution |
| 6101-2226508LL8-G2 | Width 22 mm | In distribution |
| 6101-2102211NC-G2 | Length 22 mm | In distribution |
| 6101-2121807HP-G2 | Height 7 mm | In distribution |
| SP-2260-42 | Height 15 mm | In distribution |
| 402-90374 | Width 14 mm | In distribution |
| 6101-2224014LL12-G2 | Height 14 mm | In distribution |
| 6101-2185510LL8-G2 | Height 10 mm | In distribution |
| 6101-2102810NT18-G2 | Width 10 mm | In distribution |
| 6101-2853210NC-G2 | Length 32 mm | In distribution |
| 6101-2225011LL12-G2 | Width 22 mm | In distribution |
| 6101-2185020LL8-G2 | Angle 8 ° | In distribution |
| 6101-2122008HL7-G2 | Angle 7 ° | In distribution |
| 6101-2123610TL7-G2 | Width 12 mm | In distribution |
| 6101-2121815HL7-G2 | Length 12.5 mm | In distribution |
| 6101-2122811TL7-G2 | Width 12 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 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
| Peridot-PT Anterior Cervical Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 528 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| K2M, Inc. | 510(k) number | 2021-05-07 | Class II | Labeling Change Control | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm | 3 units | 2023-03-08 |
| K2M, Inc. | 510(k) number | 2021-05-07 | Class II | Labeling Change Control | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm | 7 units | 2023-03-08 |
| K2M, Inc. | 510(k) number | 2021-05-07 | Class II | Labeling Change Control | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm | 3 units | 2023-03-08 |
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.