Asfora Bullet Cage® System
14mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at…
14mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
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 | Medical Designs, 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 |
| 510(k) | K112648 |
| Record published | 2016-09-27 |
| Record revised | 2025-07-14 (version 4) |
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 | Outer diameter 10 to 18 mm; length 21 to 25 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-9902-FD5 | Outer Diameter 14 mm | In distribution |
| 11-9902-FD2 | Outer Diameter 10 mm | In distribution |
| 11-9905-FD31-1 | In distribution | |
| 11-9905-FD45 | In distribution | |
| 11-9905-FD31-2 | In distribution | |
| 11-9905-FD7 | In distribution | |
| 11-9905-FD29 | In distribution | |
| 11-9905-FD5 | In distribution | |
| 11-9905-FD2 | In distribution | |
| 11-9905-FD36 | In distribution | |
| 11-9905-FD44 | In distribution | |
| 11-9905-FD3 | In distribution | |
| 11-9905-FD35 | In distribution | |
| 11-9905-FD34 | In distribution | |
| 11-9905-FD58 | In distribution | |
| 11-9905-FD6 | In distribution | |
| 11-9905-FD17 | In distribution | |
| 11-9902-FD10 | Outer Diameter 18 mm | In distribution |
| 11-9905-FD57 | In distribution | |
| 11-9905-FD48 | In distribution | |
| 11-9905-FD26 | In distribution | |
| 11-9905-FD25 | In distribution | |
| 11-9902-FD1 | Length 21 mm | In distribution |
| 11-9905-FD19 | In distribution | |
| 11-9905-FD39 | In distribution | |
| 11-9905-FD23 | In distribution | |
| 11-9905-FD37 | In distribution | |
| 11-9905-FD8 | In distribution | |
| 11-9905-FD61 | In distribution | |
| 11-9905-FD30 | In distribution | |
| 11-9905-FD11 | In distribution | |
| 11-9905-FD42 | In distribution | |
| 11-9905-FD1 | In distribution | |
| 11-9905-FD60 | In distribution | |
| 11-9905-FD13 | In distribution | |
| 11-9905-FD22 | In distribution | |
| 11-9905-FD9 | In distribution | |
| 11-9905-FD46 | In distribution | |
| 11-9905-FD138 | In distribution | |
| 11-9905-FD18 | In distribution | |
| 11-9905-FD12 | In distribution | |
| 11-9902-FD7 | In distribution | |
| 11-9905-FD16 | In distribution | |
| 11-9905-FD4 | In distribution | |
| 11-9905-FD24 | In distribution | |
| 11-9905-FD40 | In distribution | |
| 11-9905-FD59 | In distribution | |
| 11-9905-FD32 | In distribution | |
| 11-9902-FD9 | Outer Diameter 18 mm | In distribution |
| 11-9905-FD43 | In distribution | |
| 11-9905-FD64 | In distribution | |
| 11-9905-FD63 | In distribution | |
| 11-9905-FD49 | In distribution | |
| 11-9905-FD47 | In distribution | |
| 11-9902-FD6 | Outer Diameter 14 mm | In distribution |
| 11-9905-FD15 | In distribution | |
| 11-9905-FD33 | In distribution | |
| 11-9905-FD31-3 | In distribution | |
| 11-9902-FD3 | Outer Diameter 12 mm | In distribution |
| 11-9905-FD62 | In distribution | |
| 11-9905-FD10 | In distribution | |
| 11-9905-FD14 | In distribution | |
| 11-9902-FD8 | Outer Diameter 16 mm | In distribution |
| 11-9905-FD28 | In distribution | |
| 11-9902-FD4 | Outer Diameter 12 mm | In distribution |
| 11-9905-FD41 | In distribution |
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 |
|---|---|
| K181591 | 2018-09-26 |
| K112648 | 2012-03-13 |
| K090048 | 2009-08-14 |
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.