Cascadia™ Interbody System
AL Interbody, Size 28x36mm, A=17mm, P=11mm, 15 Degrees
14manufacturers in China registered for this device type
1,352catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K150481 |
| Record published | 2016-08-02 |
| Record revised | 2026-05-20 (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 42 mm; angle 5 to 30 ° |
| Distribution end date | 2025-12-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6101-2111608HP-G2 | Length 11.5 mm | In distribution |
| 6101-2141812CC-G2 | CONVEX | In distribution |
| 6101-2186015LP-G2 | Width 18 mm | In distribution |
| 6101-2852808NT12-G2 | Length 28 mm | In distribution |
| 6101-2102808NL12-G2 | Length 28 mm | In distribution |
| 6101-2224516LL12-G2 | Width 22 mm | In distribution |
| SP-2437-46 | Width 14 mm | In distribution |
| SP-2437-07 | Height 11 mm | In distribution |
| 6101-2102811NC-G2 | Length 28 mm | In distribution |
| 6101-2226012LP-G2 | Width 22 mm | In distribution |
| 6101-2102811NL12-G2 | Length 28 mm | In distribution |
| SP-2437-43 | Length 12 mm | In distribution |
| 6101-2102815NC-G2 | Length 28 mm | In distribution |
| 6101-2225513LL8-G2 | Length 55 mm | In distribution |
| 6101-2324218AL20-G2 | Length 32 mm | In distribution |
| 402-90577 | In distribution | |
| 6101-90044 | Angle 18 ° | In distribution |
| 6101-2852207NL6-G2 | Width 8.5 mm | In distribution |
| 6101-2102809NL12-G2 | Length 28 mm | In distribution |
| 402-90626 | Length 12.5 mm | In distribution |
| 6101-2121413CL12-G2 | Length 12 mm | In distribution |
| 6101-2102804NL6-G2 | Angle 6 ° | In distribution |
| 7908-42F223 | Height 22 mm | In distribution |
| 6101-2224510LL15-G2 | Angle 15 ° | In distribution |
| 6101-90166 | In distribution | |
| 6101-2103216TL7-G2 | Length 32 mm | In distribution |
| 6101-90128 | Width 18 mm | In distribution |
| 6101-2184011LP-G2 | Width 18 mm | In distribution |
| 6101-2224516LL15-G2 | Height 16 mm | In distribution |
| 6101-2103206TL7-G2 | Length 32 mm | In distribution |
| 6101-2324215AL20-G2 | Length 32 mm | In distribution |
| SP-2437-14 | Width 14 mm | In distribution |
| 6101-2852214NL6-G2 | Height 14 mm | In distribution |
| 6101-2226512LL8-G2 | Width 22 mm | In distribution |
| 6101-2324212AC-G2 | Length 32 mm | In distribution |
| 6101-2224516LP-G2 | Length 45 mm | In distribution |
| 6101-2225020LL8-G2 | Height 20 mm | In distribution |
| SP-2437-39 | Height 12 mm | In distribution |
| 6101-2852204NL12-G2 | Angle 12 ° | In distribution |
| 6101-2184020LP-G2 | Height 20 mm | In distribution |
| 6101-2102815TL7-G2 | Angle 7 ° | In distribution |
| 6101-2121408CL7-G2 | Height 8 mm | In distribution |
| 7908-41F16R | Height 16 mm | In distribution |
| 6101-90818 | Length 22 mm | In distribution |
| 6101-2102807NC-G2 | Length 28 mm | In distribution |
| 6101-90833 | Width 8.5 mm | In distribution |
| 6101-90132 | Height 12 mm | In distribution |
| 6101-2324220AL5-G2 | Height 20 mm | In distribution |
| 7902-90003 | Length 50 mm | In distribution |
| SP-2260-51 | Width 14 mm | In distribution |
| 6101-2852205NL12-G2 | Angle 12 ° | In distribution |
| 6101-90121 | Height 12 mm | In distribution |
| 6101-2304010AL5-G2 | Height 10 mm | In distribution |
| 6101-2102812NL12-G2 | Length 28 mm | In distribution |
| 6101-2283617AL15-G2 | Width 36 mm | In distribution |
| 6101-2103205NL6-G2 | Height 5 mm | In distribution |
| SP-2437-69 | Width 14 mm | In distribution |
| 6101-2852812NL6-G2 | Width 8.5 mm | In distribution |
| 6101-2185010LP-G2 | Width 18 mm | In distribution |
| 6101-2224016LL8-G2 | Height 16 mm | In distribution |
| 6101-2304016AL10-G2 | Length 30 mm | In distribution |
| 6101-90045 | Angle 18 ° | In distribution |
| 6101-2243012AL20-G2 | Length 24 mm | In distribution |
| 6101-2243012AL15-G2 | Width 30 mm | In distribution |
| 6101-2224510LP-G2 | Width 22 mm | In distribution |
| 6101-2243015AL20-G2 | Height 15 mm | In distribution |
| 6101-2852815NT6-G2 | Height 15 mm | In distribution |
| 6101-2102806NL18-G2 | Height 6 mm | In distribution |
| 6101-2304014AL10-G2 | Length 30 mm | In distribution |
| SP-2261-66 | Convex | In distribution |
| 6101-2102816NC-G2 | Length 28 mm | In distribution |
| 6101-2283620AL5-G2 | Angle 5 ° | In distribution |
| 6101-2226020LP-G2 | Height 20 mm | In distribution |
| 6101-2283612AC-G2 | Height 12 mm | In distribution |
| 6101-2226007LL8-G2 | Width 22 mm | In distribution |
| 6101-2224517LL8-G2 | Angle 8 ° | In distribution |
| 6101-90024 | Width 14 mm | In distribution |
| 6101-2852409NL6-G2 | Height 9 mm | In distribution |
| 6101-2283619AC-G2 | Width 36 mm | In distribution |
| 6101-2225514LL12-G2 | Angle 12 ° | In distribution |
| 6101-2224520LL8-G2 | Height 20 mm | In distribution |
| 6101-2225514LL15-G2 | Width 22 mm | In distribution |
| 6101-2243011AL10-G2 | Width 30 mm | In distribution |
| 6101-2324214AL15-G2 | Length 32 mm | In distribution |
| 6101-90013 | Angle 6 ° | In distribution |
| 6101-2225515LP-G2 | Length 55 mm | In distribution |
| 6101-2225014L22-G2 | Angle 22 ° | In distribution |
| 6101-2852209NL12-G2 | Angle 12 ° | In distribution |
| SP-2260-29 | Length 12 mm | In distribution |
| 6101-90081 | Height 8 mm | In distribution |
| SP-2260-43 | Length 12 mm | In distribution |
| SP-2260-61 | Width 14 mm | In distribution |
| 6101-2265014LL8-G2 | Angle 8 ° | In distribution |
| 6101-2243009AL10-G2 | Angle 10 ° | In distribution |
| 6101-2121410CC-G2 | Length 12 mm | In distribution |
| 6101-2102412NL6-G2 | Angle 6 ° | In distribution |
| 402-90585 | In distribution | |
| 402-90361 | Angle 15 ° | In distribution |
| 6101-90817 | Height 14 mm | In distribution |
| 6101-2102409NL12-G2 | Length 24 mm | In distribution |
| 6101-90816 | Length 22 mm | In distribution |
| 6101-2243021AL10-G2 | Length 24 mm | In distribution |
| 6101-2324221AC-G2 | Height 21 mm | In distribution |
| 402-90553 | In distribution | |
| 6101-2324216AC-G2 | Length 32 mm | In distribution |
| 7902-90010 | Length 60 mm | In distribution |
| 6101-2852212NL6-G2 | Length 22 mm | In distribution |
| 6101-2304019AL20-G2 | Height 19 mm | In distribution |
| 6101-2185007LL8-G2 | Length 50 mm | In distribution |
| 6101-2103211TL7-G2 | Length 32 mm | In distribution |
| 6101-2283611AL15-G2 | Angle 15 ° | In distribution |
| 6101-2103214TL7-G2 | Length 32 mm | In distribution |
| 6101-2224518LP-G2 | Width 22 mm | In distribution |
| 6101-2102814NL6-G2 | Height 14 mm | In distribution |
| 6101-2283610AC-G2 | Height 10 mm | In distribution |
| 6101-2304014AL5-G2 | Length 30 mm | In distribution |
| 402-90385 | Angle 25 ° | In distribution |
| 6101-2225008LL12-G2 | Angle 12 ° | In distribution |
| 6101-2102209NC-G2 | Length 22 mm | In distribution |
| 402-90393 | Height 5 mm | In distribution |
| 6101-2224515LL8-G2 | Angle 8 ° | In distribution |
| 6101-90049 | Angle 18 ° | In distribution |
| 6101-2304017AL15-G2 | Angle 15 ° | In distribution |
| 402-90415 | Length 13 mm | In distribution |
| 6101-2103207NL18-G2 | Length 32 mm | In distribution |
| 6101-2102811TL7-G2 | Width 10 mm | In distribution |
| 402-90604 | In distribution | |
| 6101-2102816NL6-G2 | Width 10 mm | In distribution |
| 6101-2283615AL10-G2 | Angle 10 ° | In distribution |
| 6101-2224008LL8-G2 | Width 22 mm | In distribution |
| 6101-2224509LP-G2 | Height 9 mm | In distribution |
| 6101-2852807NT18-G2 | Length 28 mm | In distribution |
| 6101-2225510LL8-G2 | Length 55 mm | In distribution |
| 6101-90823 | Width 8.5 mm | In distribution |
| 6101-2226011LL12-G2 | Length 60 mm | In distribution |
| 6101-2304013AL15-G2 | Angle 15 ° | In distribution |
| 6101-2226018LL8-G2 | Angle 8 ° | In distribution |
| 6101-2122007HL7-G2 | Angle 7 ° | In distribution |
| 6101-2225513LL12-G2 | Height 13 mm | In distribution |
| 6101-2304019AL5-G2 | Length 30 mm | In distribution |
| 6101-2225512LP-G2 | Height 12 mm | In distribution |
| 6101-2225016LL8-G2 | Angle 8 ° | In distribution |
| PRO-1165-02 | In distribution | |
| 402-90637 | Height 13 mm | In distribution |
| 402-90370 | Length 12 mm | In distribution |
| 6101-2184012LL8-G2 | Width 18 mm | In distribution |
| 6101-2225514L22-G2 | Angle 22 ° | In distribution |
| 6101-2852811NL6-G2 | Height 11 mm | In distribution |
| 6101-90832 | Width 8.5 mm | In distribution |
| 6101-2324210AL5-G2 | Height 10 mm | In distribution |
| 6101-2852808NL6-G2 | Width 8.5 mm | In distribution |
| 6101-2304013AL5-G2 | Height 13 mm | In distribution |
| 6101-2102411NL18-G2 | Width 10 mm | In distribution |
| 6101-2224508LP-G2 | Height 8 mm | In distribution |
| 402-90601 | In distribution | |
| 6101-2225016LP-G2 | Length 50 mm | In distribution |
| 6101-2103207NL6-G2 | Height 7 mm | In distribution |
| 6101-2243021AL20-G2 | Width 30 mm | In distribution |
| 6101-2243014AL20-G2 | Height 14 mm | In distribution |
| 6101-2226017LL8-G2 | Height 17 mm | In distribution |
| 402-90636 | Length 12.5 mm | In distribution |
| 6101-2852809NL12-G2 | Length 28 mm | In distribution |
| 6101-2283616AC-G2 | Height 16 mm | In distribution |
| 6101-90796 | Width 8.5 mm | In distribution |
| 6101-2225515LL8-G2 | Width 22 mm | In distribution |
| 6101-2243013AL10-G2 | Length 24 mm | In distribution |
| 6101-2852806NL6-G2 | Width 8.5 mm | In distribution |
| 6101-2283620AL20-G2 | Height 20 mm | In distribution |
| 6101-2304014AL20-G2 | Width 40 mm | In distribution |
| 402-90440 | Angle 30 ° | In distribution |
| 6101-2225513LP-G2 | Height 13 mm | In distribution |
| 6101-2102814NL12-G2 | Length 28 mm | In distribution |
| 6101-2243015AL15-G2 | Length 24 mm | In distribution |
| 6101-2224515LP-G2 | Length 45 mm | In distribution |
| 6101-2121410CL12-G2 | Angle 12 ° | In distribution |
| 6101-2324212AL10-G2 | Height 12 mm | In distribution |
| 6101-2103208NL12-G2 | Length 32 mm | In distribution |
| 6101-90134 | Length 14 mm | In distribution |
| 6101-90027 | Angle 7 ° | In distribution |
| 6101-2102215NC-G2 | Length 22 mm | In distribution |
| SP-2261-54 | Width 16 mm | In distribution |
| 6101-2225019LL8-G2 | Length 50 mm | In distribution |
| 6101-2243011AL15-G2 | Angle 15 ° | In distribution |
| 6101-2283615AL20-G2 | Height 15 mm | In distribution |
| 402-90558 | In distribution | |
| 6101-90192 | Angle 12 ° | In distribution |
| PRO-1238-20 | Width 16 mm | In distribution |
| 6101-2103612TL7-G2 | Angle 7 ° | In distribution |
| 6101-2143213NC-G2 | Length 32 mm | In distribution |
| 6101-2185015LP-G2 | Length 50 mm | In distribution |
| 6101-2224018LP-G2 | Width 22 mm | In distribution |
| 6101-2121409CC-G2 | Length 12 mm | In distribution |
| 6101-2224513LP-G2 | Height 13 mm | In distribution |
| 6101-2226020LL8-G2 | Length 60 mm | In distribution |
| 6101-2226019LP-G2 | Width 22 mm | In distribution |
| 6101-2852808NL18-G2 | Width 8.5 mm | In distribution |
| 6101-2243013AL5-G2 | Length 24 mm | In distribution |
| 6101-2304011AL15-G2 | Angle 15 ° | In distribution |
| 6101-2102408NL6-G2 | Height 8 mm | In distribution |
| 6101-2225009LL12-G2 | Angle 12 ° | In distribution |
| 402-90579 | In distribution | |
| 6101-90828 | Length 22 mm | In distribution |
| 402-90617 | Length 11.5 mm | In distribution |
| 6101-2225014LL8-G2 | Height 14 mm | In distribution |
| 6101-2102807NL18-G2 | Angle 18 ° | In distribution |
| 6101-2324215AL15-G2 | Width 42 mm | In distribution |
| 6101-2225008LL8-G2 | Angle 8 ° | In distribution |
| SP-2261-57 | Angle 30 ° | In distribution |
| 6101-2224014LL8-G2 | Angle 8 ° | In distribution |
| SP-2260-46 | Width 14 mm | In distribution |
| 6101-2324219AL15-G2 | Height 19 mm | In distribution |
| 402-90635 | Height 11 mm | In distribution |
| 6101-2102805NL18-G2 | Length 28 mm | In distribution |
| 402-90339 | Length 12 mm | In distribution |
| 6101-2226012LL8-G2 | Width 22 mm | In distribution |
| 6101-2224007LL8-G2 | Height 7 mm | In distribution |
| 402-90576 | In distribution | |
| SP-2260-17 | Length 12 mm | In distribution |
| 6101-90123 | Height 14 mm | In distribution |
| 6101-2102806NL12-G2 | Angle 12 ° | In distribution |
| 6101-90182 | Angle 6 ° | In distribution |
| 6101-90025 | Width 14 mm | In distribution |
| 402-90422 | Height 15 mm | In distribution |
| 6101-2224512LP-G2 | Height 12 mm | In distribution |
| 6101-90183 | Angle 12 ° | In distribution |
| 6101-2324215AL5-G2 | Length 32 mm | In distribution |
| 6101-2243019AL20-G2 | Length 24 mm | In distribution |
| 6101-2304009AL10-G2 | Length 30 mm | In distribution |
| 6101-90803 | Angle 6 ° | In distribution |
| 6101-90824 | Length 22 mm | In distribution |
| 6101-90815 | Height 12 mm | In distribution |
| 6101-2186011LP-G2 | Height 11 mm | In distribution |
| SP-2437-35 | Height 8 mm | In distribution |
| 402-90357 | Width 14 mm | In distribution |
| 6101-2852213NL6-G2 | Width 8.5 mm | In distribution |
| 6101-90030 | Angle 6 ° | In distribution |
| 6101-2324219AL20-G2 | Width 42 mm | In distribution |
| 6101-2852205NL6-G2 | Height 5 mm | In distribution |
| 6101-2102408NL18-G2 | Width 10 mm | In distribution |
| 6101-2324212AL5-G2 | Angle 5 ° | In distribution |
| 6101-2185512LL8-G2 | Width 18 mm | In distribution |
| 6101-2304012AL15-G2 | Angle 15 ° | In distribution |
| 6101-90014 | Angle 6 ° | In distribution |
| 6101-2226011LL8-G2 | Height 11 mm | In distribution |
| 6101-90198 | Angle 18 ° | In distribution |
| 6101-2184508LL8-G2 | Height 8 mm | In distribution |
| 6101-2243010AL5-G2 | Width 30 mm | In distribution |
| 6101-2283614AL10-G2 | Angle 10 ° | In distribution |
| 6101-2283616AL20-G2 | Length 28 mm | In distribution |
| 6101-2224019LP-G2 | Length 40 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.