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…

Registry build 21.09.26

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.

14manufacturers in China registered for this device type
66catalogue numbers in this listing
3510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code MAX
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

Regulatory record for Asfora Bullet Cage® System
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

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 numbers for Asfora Bullet Cage® System
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

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

FDA premarket approvals naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer