Fortilink-L IBF System With TETRAfuse 3d Technology
Fortilink-L Interbody Fusion Device (IBF) System with TETRAfuse 3D Technology, 18mm (W), 55mm (L), 11mm (H), 12° Lordosis
14manufacturers in China registered for this device type
76catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Pioneer Surgical Technology, Inc., United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2017-10-30 |
| Record revised | 2026-02-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-07-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 65-L-1450-13 | 14mm (W), 50mm (L), 13mm (H) | Withdrawn |
| 65-L-2255-9-6L | 22mm (W), 55mm (L), 9mm (H), 6° Lordosis | Withdrawn |
| 65-L-1850-9 | 18mm (W), 50mm (L), 9mm (H) | Withdrawn |
| 65-L-2660-11-6L | 26mm (W), 60mm (L), 11mm (H), 6° Lordosis | Withdrawn |
| 65-L-1845-8 | 18mm (W), 45mm (L), 8mm (H) | Withdrawn |
| 65-L-1855-15-6L | 18mm (W), 55mm (L), 15mm (H), 6° Lordosis | Withdrawn |
| 65-L-1845-11 | 18mm (W), 45mm (L), 11mm (H) | Withdrawn |
| 65-L-1855-9 | 18mm (W), 55mm (L), 9mm (H) | Withdrawn |
| 65-L-2650-13-6L | 26mm (W), 50mm (L), 13mm (H), 6° Lordosis | Withdrawn |
| 65-L-1855-11-12L | 18mm (W), 55mm (L), 11mm (H), 12° Lordosis | Withdrawn |
| 65-L-2660-13-6L | 26mm (W), 60mm (L), 13mm (H), 6° Lordosis | Withdrawn |
| 65-L-2650-13-12L | 26mm (W), 50mm (L), 13mm (H), 12° Lordosis | Withdrawn |
| 65-L-2245-11 | 22mm (W), 45mm (L), 11mm (H) | Withdrawn |
| 65-L-1840-13-6L | 18mm (W), 40mm (L), 13mm (H), 6° Lordosis | Withdrawn |
| 65-L-2645-15-6L | 26mm (W), 45mm (L), 15mm (H), 6° Lordosis | Withdrawn |
| 65-L-2655-13-6L | 26mm (W), 55mm (L), 13mm (H), 6° Lordosis | Withdrawn |
| 65-L-1860-13-12L | 18mm (W), 60mm (L), 13mm (H), 12° Lordosis | Withdrawn |
| 65-L-2245-15-12L | 22mm (W), 45mm (L), 15mm (H), 12° Lordosis | Withdrawn |
| 65-L-1450-11 | 14mm (W), 50mm (L), 11mm (H) | Withdrawn |
| 65-L-1855-13 | 18mm (W), 55mm (L), 13mm (H) | Withdrawn |
| 65-L-2250-13-6L | 22mm (W), 50mm (L), 13mm (H), 6° Lordosis | Withdrawn |
| 65-L-2255-8 | 22mm (W), 55mm (L), 8mm (H) | Withdrawn |
| 65-L-2655-9-6L | 26mm (W), 55mm (L), 9mm (H), 6° Lordosis | Withdrawn |
| 65-L-1860-11-12L | 18mm (W), 60mm (L), 11mm (H), 12° Lordosis | Withdrawn |
| 65-L-2650-9-6L | 26mm (W), 50mm (L), 9mm (H), 6° Lordosis | Withdrawn |
| 65-L-2255-11-12L | 22mm (W), 55mm (L), 11mm (H), 12° Lordosis | Withdrawn |
| 65-L-1860-11-6L | 18mm (W), 60mm (L), 11mm (H), 6° Lordosis | Withdrawn |
| 65-L-1840-9-6L | 18mm (W), 40mm (L), 9mm (H), 6° Lordosis | Withdrawn |
| 65-L-2645-13-12L | 26mm (W), 45mm (L), 13mm (H), 12° Lordosis | Withdrawn |
| 65-L-1860-15-6L | 18mm (W), 60mm (L), 15mm (H), 6° Lordosis | Withdrawn |
| 65-L-2250-15 | 22mm (W), 50mm (L), 15mm (H) | Withdrawn |
| 65-L-1450-11-6L | 14mm (W), 50mm (L), 11mm (H), 6° Lordosis | Withdrawn |
| 65-L-2650-15-6L | 26mm (W), 50mm (L), 15mm (H), 6° Lordosis | Withdrawn |
| 65-L-2245-7 | 22mm (W), 45mm (L), 7mm (H) | Withdrawn |
| 65-L-1440-15-6L | 14mm (W), 40mm (L), 15mm (H), 6° Lordosis | Withdrawn |
| 65-L-1450-8 | 14mm (W), 50mm (L), 8mm (H) | Withdrawn |
| 65-L-1440-15 | 14mm (W), 40mm (L), 15mm (H) | Withdrawn |
| 65-L-1445-13 | 14mm (W), 45mm (L), 13mm (H) | Withdrawn |
| 65-L-1855-15 | 18mm (W), 55mm (L), 15mm (H) | Withdrawn |
| 65-L-2255-11 | 22mm (W), 55mm (L), 11mm (H) | Withdrawn |
| 65-L-1845-7 | 18mm (W), 45mm (L), 7mm (H) | Withdrawn |
| 65-L-1855-9-6L | 18mm (W), 55mm (L), 9mm (H), 6° Lordosis | Withdrawn |
| 65-L-1845-15 | 18mm (W), 45mm (L), 15mm (H) | Withdrawn |
| 65-L-2250-7 | 22mm (W), 50mm (L), 7mm (H) | Withdrawn |
| 65-L-2255-13-12L | 22mm (W), 55mm (L), 13mm (H), 12° Lordosis | Withdrawn |
| 65-L-1440-11-6L | 14mm (W), 40mm (L), 11mm (H), 6° Lordosis | Withdrawn |
| 65-L-2250-15-12L | 22mm (W), 50mm (L), 15mm (H), 12° Lordosis | Withdrawn |
| 65-L-1455-9 | 14mm (W), 55mm (L), 9mm (H) | Withdrawn |
| 65-L-1845-9 | 18mm (W), 45mm (L), 9mm (H) | Withdrawn |
| 65-L-2255-9 | 22mm (W), 55mm (L), 9mm (H) | Withdrawn |
| 65-L-1850-9-6L | 18mm (W), 50mm (L), 9mm (H), 6° Lordosis | Withdrawn |
| 65-L-1445-15-6L | 14mm (W), 45mm (L), 15mm (H), 6° Lordosis | Withdrawn |
| 65-L-1855-11 | 18mm (W), 55mm (L), 11mm (H) | Withdrawn |
| 65-L-1445-13-6L | 14mm (W), 45mm (L), 13mm (H), 6° Lordosis | Withdrawn |
| 65-L-1440-13 | 14mm (W), 40mm (L), 13mm (H) | Withdrawn |
| 65-L-1845-15-12L | 18mm (W), 45mm (L), 15mm (H), 12° Lordosis | Withdrawn |
| 65-L-1445-8 | 14mm (W), 45mm (L), 8mm (H) | Withdrawn |
| 65-L-2245-11-12L | 22mm (W), 45mm (L), 11mm (H), 12° Lordosis | Withdrawn |
| 65-L-1450-9 | 14mm (W), 50mm (L), 9mm (H) | Withdrawn |
| 65-L-1440-7 | 14mm (W), 40mm (L), 7mm (H) | Withdrawn |
| 65-L-2260-15-12L | 22mm (W), 60mm (L), 15mm (H), 12° Lordosis | Withdrawn |
| 65-L-1845-13-6L | 18mm (W), 45mm (L), 13mm (H), 6° Lordosis | Withdrawn |
| 65-L-1845-11-6L | 18mm (W), 45mm (L), 11mm (H), 6° Lordosis | Withdrawn |
| 65-L-2245-11-6L | 22mm (W), 45mm (L), 11mm (H), 6° Lordosis | Withdrawn |
| 65-L-1855-11-6L | 18mm (W), 55mm (L), 11mm (H), 6° Lordosis | Withdrawn |
| 65-L-1445-9 | 14mm (W), 45mm (L), 9mm (H) | Withdrawn |
| 65-L-1445-9-6L | 14mm (W), 45mm (L), 9mm (H), 6° Lordosis | Withdrawn |
| 65-L-1440-9-6L | 14mm (W), 40mm (L), 9mm (H), 6° Lordosis | Withdrawn |
| 65-L-1840-15-6L | 18mm (W), 40mm (L), 15mm (H), 6° Lordosis | Withdrawn |
| 65-L-2260-15 | 22mm (W), 60mm (L), 15mm (H) | Withdrawn |
| 65-L-1855-13-12L | 18mm (W), 55mm (L), 13mm (H), 12° Lordosis | Withdrawn |
| 65-L-2245-15 | 22mm (W), 45mm (L), 15mm (H) | Withdrawn |
| 65-L-2655-11-6L | 26mm (W), 55mm (L), 11mm (H), 6° Lordosis | Withdrawn |
| 65-L-2260-11 | 22mm (W), 60mm (L), 11mm (H) | Withdrawn |
| 65-L-2660-15-6L | 26mm (W), 60mm (L), 15mm (H), 6° Lordosis | Withdrawn |
| 65-L-1855-7 | 18mm (W), 55mm (L), 7mm (H) | Withdrawn |
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 |
|---|---|
| K133455 | 2014-03-27 |
| K112496 | 2011-09-28 |
| K073177 | 2008-05-13 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-05-21 | Class II | Error in labeling | Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial. | 18 | 2015-10-29 |
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.