Navagio
Lumbar Cage, 27x12mm 14-Degree OB CRV
14manufacturers in China registered for this device type
254catalogue numbers in this listing
1510(k) clearance
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 | Kalitec Direct, LLC, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2022-06-06 |
| Record revised | 2022-06-14 (version 2) |
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, manufacturing date |
| Distribution end date | 2022-06-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-TEC-2712 | In distribution | |
| 30-TEA-2708 | In distribution | |
| 30-TTA-2709 | In distribution | |
| 30-TEC-3612 | In distribution | |
| 30-TEA-2711 | In distribution | |
| 30-TES-2709 | In distribution | |
| 30-TEA-2716 | In distribution | |
| 30-TEA-3209 | In distribution | |
| 30-TEA-3212 | In distribution | |
| 30-TTS-3613 | In distribution | |
| 30-TEC-2709 | In distribution | |
| 30-PES-2509 | In distribution | |
| 30-TES-3610 | In distribution | |
| 30-TTS-3611 | In distribution | |
| 30-TTC-2714 | In distribution | |
| 30-TNA-3213 | In distribution | |
| 30-TES-2716 | In distribution | |
| 30-TEA-3609 | In distribution | |
| 30-TEC-2710 | In distribution | |
| 30-TTA-2716 | In distribution | |
| 30-TES-2715 | In distribution | |
| 30-TTS-3614 | In distribution | |
| 30-TEA-2715 | In distribution | |
| 30-TTC-2715 | In distribution | |
| 30-TEC-3616 | In distribution | |
| 30-TTA-2708 | In distribution | |
| 30-TTA-3616 | In distribution | |
| 30-PNS-2510 | In distribution | |
| 30-TNC-2712 | In distribution | |
| 30-TTC-2712 | In distribution | |
| 30-TES-2711 | In distribution | |
| 30-TEA-2712 | In distribution | |
| 30-TTC-3213 | In distribution | |
| 30-TNS-2711 | In distribution | |
| 30-TTS-3215 | In distribution | |
| 30-TTA-2714 | In distribution | |
| 30-TNS-2715 | In distribution | |
| 30-TNA-3212 | In distribution | |
| 30-TEC-3215 | In distribution | |
| 30-PTS-2512 | In distribution | |
| 30-TTS-3612 | In distribution | |
| 30-TTA-3609 | In distribution | |
| 30-TNS-3211 | In distribution | |
| 30-TES-3213 | In distribution | |
| 30-TNC-2716 | In distribution | |
| 30-TTA-2715 | In distribution | |
| 30-TTC-2711 | In distribution | |
| 30-TTC-2708 | In distribution | |
| 30-TNC-2710 | In distribution | |
| 30-TTS-3213 | In distribution | |
| 30-TTS-3212 | In distribution | |
| 30-TTC-2716 | In distribution | |
| 30-PES-2515 | In distribution | |
| 30-TNC-3609 | In distribution | |
| 30-TTS-3609 | In distribution | |
| 30-TTC-2709 | In distribution | |
| 30-TNS-3213 | In distribution | |
| 30-TEA-3211 | In distribution | |
| 30-TTC-3611 | In distribution | |
| 30-TTS-2708 | In distribution | |
| 30-TNA-3610 | In distribution | |
| 30-TNA-2708 | In distribution | |
| 30-TTC-3210 | In distribution | |
| 30-PES-2516 | In distribution | |
| 30-TTS-2714 | In distribution | |
| 30-TTS-2711 | In distribution | |
| 30-TNC-3213 | In distribution | |
| 30-TEC-2714 | In distribution | |
| 30-TTS-3616 | In distribution | |
| 30-TTS-2715 | In distribution | |
| 30-TTA-3211 | In distribution | |
| 30-TNC-3208 | In distribution | |
| 30-PNS-2515 | In distribution | |
| 30-PES-2511 | In distribution | |
| 30-PTS-2516 | In distribution | |
| 30-TEA-3613 | In distribution | |
| 30-TNA-3615 | In distribution | |
| 30-TEA-3210 | In distribution | |
| 30-TEC-3214 | In distribution | |
| 30-TEC-3216 | In distribution | |
| 30-TNA-3616 | In distribution | |
| 30-TES-3214 | In distribution | |
| 30-PNS-2512 | In distribution | |
| 30-TEA-3215 | In distribution | |
| 30-TNA-2714 | In distribution | |
| 30-TNC-3612 | In distribution | |
| 30-TTA-3212 | In distribution | |
| 30-TNS-3616 | In distribution | |
| 30-TTS-2713 | In distribution | |
| 32-TNS-3216 | In distribution | |
| 30-TNA-2712 | In distribution | |
| 30-TEC-3211 | In distribution | |
| 30-PES-2510 | In distribution | |
| 30-TNC-3211 | In distribution | |
| 30-TTS-2710 | In distribution | |
| 30-TES-3215 | In distribution | |
| 30-TNA-3613 | In distribution | |
| 30-TTS-3209 | In distribution | |
| 30-PNS-2514 | In distribution | |
| 30-PTS-2510 | In distribution | |
| 30-TEA-3614 | In distribution | |
| 30-TNS-3610 | In distribution | |
| 30-TEC-3610 | In distribution | |
| 30-TTA-3208 | In distribution | |
| 30-TNS-2709 | In distribution | |
| 30-TTA-3614 | In distribution | |
| 30-TTC-3611 | In distribution | |
| 30-TES-3614 | In distribution | |
| 30-TNS-3210 | In distribution | |
| 30-PNS-2513 | In distribution | |
| 30-TES-3211 | In distribution | |
| 30-TEC-2715 | In distribution | |
| 30-TNA-2715 | In distribution | |
| 30-PTS-2509 | In distribution | |
| 30-TTS-3210 | In distribution | |
| 30-TES-3210 | In distribution | |
| 30-TEA-3208 | In distribution | |
| 30-TTA-3216 | In distribution | |
| 30-TTS-3216 | In distribution | |
| 30-TTC-3209 | In distribution | |
| 30-TTA-3613 | In distribution | |
| 30-PES-2513 | In distribution | |
| 30-TTC-3616 | In distribution | |
| 30-TTC-2713 | In distribution | |
| 30-TNC-3212 | In distribution | |
| 30-TEA-3616 | In distribution | |
| 30-PNS-2508 | In distribution | |
| 30-TNC-2714 | In distribution | |
| 30-TNC-2713 | In distribution | |
| 30-TEC-3611 | In distribution | |
| 30-TNC-3616 | In distribution | |
| 30-TNS-3613 | In distribution | |
| 30-TNC-3610 | In distribution | |
| 30-TNC-3210 | In distribution | |
| 30-PES-2514 | In distribution | |
| 30-TNS-3608 | In distribution | |
| 30-TES-3612 | In distribution | |
| 30-TTC-3615 | In distribution | |
| 30-TES-3216 | In distribution | |
| 30-TNS-3208 | In distribution | |
| 30-PTS-2515 | In distribution | |
| 30-TNS-2708 | In distribution | |
| 30-PNS-2509 | In distribution | |
| 30-TNC-3614 | In distribution | |
| 30-TEC-3213 | In distribution | |
| 30-TNC-3216 | In distribution | |
| 30-TTA-3215 | In distribution | |
| 30-PTS-2514 | In distribution | |
| 30-TTS-3615 | In distribution | |
| 30-TNA-3210 | In distribution | |
| 30-TNC-2711 | In distribution | |
| 30-TTC-3610 | In distribution | |
| 30-TTC-3216 | In distribution | |
| 30-TES-3616 | In distribution | |
| 30-TTS-2716 | In distribution | |
| 30-TNS-3615 | In distribution | |
| 30-TNS-3609 | In distribution | |
| 30-TEC-3613 | In distribution | |
| 30-TNA-2716 | In distribution | |
| 30-TTA-3615 | In distribution | |
| 30-TES-3613 | In distribution | |
| 30-TTA-2710 | In distribution | |
| 30-TNS-2710 | In distribution | |
| 30-TNC-3613 | In distribution | |
| 30-TTC-3614 | In distribution | |
| 30-TTA-2711 | In distribution | |
| 30-TNS-3209 | In distribution | |
| 30-TTC-3609 | In distribution | |
| 30-TES-2710 | In distribution | |
| 30-TTA-3611 | In distribution | |
| 30-TEA-3608 | In distribution | |
| 30-PES-2512 | In distribution | |
| 30-TEA-3214 | In distribution | |
| 30-TNS-3612 | In distribution | |
| 30-TTA-3209 | In distribution | |
| 30-TEC-2711 | In distribution | |
| 30-TEC-3615 | In distribution | |
| 30-TEA-2713 | In distribution | |
| 30-TNC-3215 | In distribution | |
| 30-TTC-3212 | In distribution | |
| 30-TES-2714 | In distribution | |
| 30-TTS-3211 | In distribution | |
| 30-TNC-3615 | In distribution | |
| 30-TES-3611 | In distribution | |
| 30-TEA-3611 | In distribution | |
| 30-TNA-3611 | In distribution | |
| 30-TNS-2713 | In distribution | |
| 30-PNS-2516 | In distribution | |
| 30-TTC-3610 | In distribution | |
| 30-TEC-3614 | In distribution | |
| 30-TNS-3212 | In distribution | |
| 30-TNA-3608 | In distribution | |
| 30-TES-3615 | In distribution | |
| 30-TEA-3610 | In distribution | |
| 30-TNS-2712 | In distribution | |
| 30-TNA-3215 | In distribution | |
| 30-TNC-3608 | In distribution | |
| 30-TNS-2714 | In distribution | |
| 30-TNA-3209 | In distribution | |
| 30-TNS-3614 | In distribution | |
| 30-TEA-2710 | In distribution | |
| 30-TTS-3214 | In distribution | |
| 30-TNS-2716 | In distribution | |
| 30-TNC-3611 | In distribution | |
| 30-PS-2511 | In distribution | |
| 30-TNC-2708 | In distribution | |
| 30-TNS-3215 | In distribution | |
| 30-TES-3212 | In distribution | |
| 30-TNC-2709 | In distribution | |
| 30-TTA-2712 | In distribution | |
| 30-TEA-2709 | In distribution | |
| 30-TTA-2713 | In distribution | |
| 30-TEC-3212 | In distribution | |
| 30-TTA-3608 | In distribution | |
| 30-TNA-3214 | In distribution | |
| 30-TEC-3210 | In distribution | |
| 30-TES-2713 | In distribution | |
| 30-TNS-3611 | In distribution | |
| 30-TNC-2715 | In distribution | |
| 30-PNS-2511 | In distribution | |
| 30-TTA-3214 | In distribution | |
| 30-PTS-2508 | In distribution | |
| 30-TEA-3612 | In distribution | |
| 30-TEA-3615 | In distribution | |
| 30-TNA-3211 | In distribution | |
| 30-PTS-2513 | In distribution | |
| 30-TNA-3614 | In distribution | |
| 30-TEA-3216 | In distribution | |
| 30-TNC-3214 | In distribution | |
| 30-TNA-3609 | In distribution | |
| 30-TTA-3612 | In distribution | |
| 30-TTC-3214 | In distribution | |
| 30-TTS-3610 | In distribution | |
| 30-TNS-3214 | In distribution | |
| 30-TNC-3209 | In distribution | |
| 30-TTC-3211 | In distribution | |
| 30-TEA-3213 | In distribution | |
| 30-TEC-2713 | In distribution | |
| 30-TTC-3613 | In distribution | |
| 30-TEA-2714 | In distribution | |
| 30-TES-2712 | In distribution | |
| 30-TTC-3215 | In distribution | |
| 30-TNA-3216 | In distribution | |
| 30-TTS-2709 | In distribution | |
| 30-TTS-2712 | In distribution | |
| 30-TNA-2710 | In distribution | |
| 30-TTA-3210 | In distribution | |
| 30-TNA-2709 | In distribution | |
| 30-TTA-3610 | In distribution | |
| 30-TEC-2716 | In distribution |
Showing 250 of 254 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123100 | 2013-03-28 |
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.