ShurFit Lumbar Interbody
ShurFit Lumbar Interbody System provides graft-holding spacers that support the disc space during lumbar fusion. The family includes straight PLIF, oblique T-PLIF, curved TLIF, anterior and…
ShurFit Lumbar Interbody System provides graft-holding spacers that support the disc space during lumbar fusion. The family includes straight PLIF, oblique T-PLIF, curved TLIF, anterior and lateral configurations.
Implants are either additively manufactured titanium alloy or PEEK. PEEK forms have tantalum markers and may be uncoated or coated with commercially pure titanium and hydroxyapatite.
Listed Item
22 x 09mm 12° Straight PEEK 2C Interbody
Construct and Supply Options
PLIF uses two implants per disc space; the other named configurations use one. The system is intended for one or two contiguous levels from L2 to S1 with autograft and supplemental fixation. Uncoated PEEK implants are supplied nonsterile, while titanium and coated PEEK implants are sterile.
14manufacturers in China registered for this device type
1,399catalogue numbers in this listing
2510(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.
| 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 | Precision Spine, 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 | Manufacturer |
| 510(k) | K212075 |
| Record published | 2023-02-27 |
| Record revised | 2025-07-21 (version 3) |
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 |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72-SPA-2612 | In distribution | |
| 72-SPA-2815 | In distribution | |
| 72-CPB-2814 | In distribution | |
| 72-CPB-3611 | In distribution | |
| 72-STD-2210 | In distribution | |
| 72-STB-2813 | In distribution | |
| 72-OTB-2410 | In distribution | |
| 72-CPC-3613-2C | In distribution | |
| 72-OPC-2810-2C | In distribution | |
| 72-STD-2615 | In distribution | |
| 72-CPB-3613 | In distribution | |
| 72-SPA-2607 | In distribution | |
| 72-SPA-3211 | In distribution | |
| 72-CTA-2413 | In distribution | |
| 72-OPC-2812 | In distribution | |
| 72-OPC-3213 | In distribution | |
| 72-CPB-2811-2C | In distribution | |
| 72-STA-2814 | In distribution | |
| 72-CTA-2408 | In distribution | |
| 72-SPD-3215 | In distribution | |
| 72-OTA-3614 | In distribution | |
| 72-SPB-2609-2C | In distribution | |
| 72-CPC-3608 | In distribution | |
| 72-STB-2608 | In distribution | |
| 72-STA-2209 | In distribution | |
| 72-STB-3211 | In distribution | |
| 72-CPD-3214-2C | In distribution | |
| 72-OPA-2808-2C | In distribution | |
| 72-CTC-2415 | In distribution | |
| 72-OPC-2412-2C | In distribution | |
| 72-SPA-2613 | In distribution | |
| 72-STB-2615 | In distribution | |
| 72-CPB-2409 | In distribution | |
| 72-SPB-2613-2C | In distribution | |
| 72-CPB-2812 | In distribution | |
| 72-CPD-3611 | In distribution | |
| 72-SPA-2210-2C | In distribution | |
| 72-SPB-3216-2C | In distribution | |
| 72-CTB-2816 | In distribution | |
| 72-CPB-2414-2C | In distribution | |
| 72-SPD-3013 | In distribution | |
| 72-OPC-2813 | In distribution | |
| 72-CPD-3212 | In distribution | |
| 72-SPB-2813-2C | In distribution | |
| 72-CPC-3212 | In distribution | |
| 72-CPC-3616-2C | In distribution | |
| 72-SPB-2815 | In distribution | |
| 72-CPB-2409-2C | In distribution | |
| 72-SPD-2612 | In distribution | |
| 72-OPA-3215 | In distribution | |
| 72-CPA-2807-2C | In distribution | |
| 72-CPB-3612-2C | In distribution | |
| 72-OPB-3609 | In distribution | |
| 72-OTB-3615 | In distribution | |
| 72-OPD-2413 | In distribution | |
| 72-OPA-3208-2C | In distribution | |
| 72-CPA-2814 | In distribution | |
| 72-CPA-3213-2C | In distribution | |
| 72-SPA-2210 | In distribution | |
| 72-SPC-2209-2C | In distribution | |
| 72-STA-2616 | In distribution | |
| 72-CTC-2813 | In distribution | |
| 72-CPA-3608-2C | In distribution | |
| 72-OPD-2414-2C | In distribution | |
| 72-STA-2816 | In distribution | |
| 72-SPB-2808-2C | In distribution | |
| 72-CPA-3215 | In distribution | |
| 72-STC-2213 | In distribution | |
| 72-OPB-2416 | In distribution | |
| 72-SPB-3216 | In distribution | |
| 72-STB-2213 | In distribution | |
| 72-OPA-2415 | In distribution | |
| 72-SPA-2213-2C | In distribution | |
| 72-CTA-2415 | In distribution | |
| 72-CPA-2416-2C | In distribution | |
| 72-CPB-3207-2C | In distribution | |
| 72-OPA-2810 | In distribution | |
| 72-STA-2409 | In distribution | |
| 72-OTB-3614 | In distribution | |
| 72-OPA-2406 | In distribution | |
| 72-OTC-2412 | In distribution | |
| 72-SPB-3210-2C | In distribution | |
| 72-STC-2214 | In distribution | |
| 72-OTA-3609 | In distribution | |
| 72-CTA-2811 | In distribution | |
| 72-SPC-2811-2C | In distribution | |
| 72-OPA-2408 | In distribution | |
| 72-SPC-3213 | In distribution | |
| 72-OPB-3214 | In distribution | |
| 72-OPB-2812-2C | In distribution | |
| 72-CTA-3610 | In distribution | |
| 72-OPA-2813 | In distribution | |
| 72-CPB-3215-2C | In distribution | |
| 72-SPB-3213 | In distribution | |
| 72-SPC-2412-2C | In distribution | |
| 72-OPB-3614-2C | In distribution | |
| 72-CPD-3211-2C | In distribution | |
| 72-OTB-3208 | In distribution | |
| 72-SPB-2413-2C | In distribution | |
| 72-SPA-2814 | In distribution | |
| 72-OPA-2411 | In distribution | |
| 72-OPB-2413-2C | In distribution | |
| 72-CPA-2412-2C | In distribution | |
| 72-SPC-2814-2C | In distribution | |
| 72-CPC-3614-2C | In distribution | |
| 72-STA-2606 | In distribution | |
| 72-CPA-2811-2C | In distribution | |
| 72-OPA-3607 | In distribution | |
| 72-CPC-2411 | In distribution | |
| 72-SPA-3006 | In distribution | |
| 72-STD-2413 | In distribution | |
| 72-OPD-2415 | In distribution | |
| 72-CPA-3216-2C | In distribution | |
| 72-OTB-2815 | In distribution | |
| 72-CPA-2406 | In distribution | |
| 72-OPC-3211-2C | In distribution | |
| 72-SPC-2610 | In distribution | |
| 72-SPB-3213-2C | In distribution | |
| 72-BK-0040 | In distribution | |
| 72-CPB-3609-2C | In distribution | |
| 72-SPD-3016-2C | In distribution | |
| 72-CTC-2410 | In distribution | |
| 72-STC-2212 | In distribution | |
| 72-STD-3014 | In distribution | |
| 72-SPC-2410 | In distribution | |
| 72-OTA-2815 | In distribution | |
| 72-CPC-3208 | In distribution | |
| 72-OPA-2408-2C | In distribution | |
| 72-CTB-2413 | In distribution | |
| 72-SPD-3216-2C | In distribution | |
| 72-CPA-2812 | In distribution | |
| 72-CPC-3209 | In distribution | |
| 72-CPD-3214 | In distribution | |
| 72-SPB-2815-2C | In distribution | |
| 72-OTA-3216 | In distribution | |
| 72-SPB-2412-2C | In distribution | |
| 72-STB-2410 | In distribution | |
| 72-SPD-2614-2C | In distribution | |
| 72-OPC-3215-2C | In distribution | |
| 72-CTA-3611 | In distribution | |
| 72-CTD-2815 | In distribution | |
| 72-CPB-3607-2C | In distribution | |
| 72-SC-1010 | In distribution | |
| 72-OTA-3215 | In distribution | |
| 72-OTA-2810 | In distribution | |
| 72-CPB-3611-2C | In distribution | |
| 72-OPD-3615-2C | In distribution | |
| 72-SPD-2611 | In distribution | |
| 72-OPC-3616-2C | In distribution | |
| 72-CTA-3211 | In distribution | |
| 72-CPB-3614-2C | In distribution | |
| 72-CTA-2409 | In distribution | |
| 72-CTA-2406 | In distribution | |
| 72-OPD-3214 | In distribution | |
| 72-SPC-3216 | In distribution | |
| 72-CPA-3210 | In distribution | |
| 72-STC-2614 | In distribution | |
| 72-SPA-3015-2C | In distribution | |
| 72-SPA-3213 | In distribution | |
| 72-CPA-2808-2C | In distribution | |
| 72-CPC-2409-2C | In distribution | |
| 72-CPD-3210 | In distribution | |
| 72-CPC-3211-2C | In distribution | |
| 72-CPC-2811 | In distribution | |
| 72-SPC-2816-2C | In distribution | |
| 72-SPC-2415-2C | In distribution | |
| 72-CPB-3216 | In distribution | |
| 72-CPB-2410 | In distribution | |
| 72-OPC-2813-2C | In distribution | |
| 72-CTB-3215 | In distribution | |
| 72-CTD-3615 | In distribution | |
| 72-OPB-2411-2C | In distribution | |
| 72-CPB-2413 | In distribution | |
| 72-OPB-2816 | In distribution | |
| 72-OTA-2407 | In distribution | |
| 72-OPA-3610 | In distribution | |
| 72-SPA-2808 | In distribution | |
| 72-CTB-2410 | In distribution | |
| 72-STC-2815 | In distribution | |
| 72-SPD-2214 | In distribution | |
| 72-STC-2811 | In distribution | |
| 72-OPC-3214 | In distribution | |
| 72-CPD-3611-2C | In distribution | |
| 72-SPC-3015-2C | In distribution | |
| 72-STD-2812 | In distribution | |
| 72-STA-3212 | In distribution | |
| 72-CPA-2407-2C | In distribution | |
| 72-STC-2816 | In distribution | |
| 72-CPA-3209 | In distribution | |
| 72-OPA-3215-2C | In distribution | |
| 72-SPB-2611 | In distribution | |
| 72-OTB-2408 | In distribution | |
| 72-OPB-2416-2C | In distribution | |
| 72-SPA-3215 | In distribution | |
| 72-OPA-3211 | In distribution | |
| 72-CPB-2411 | In distribution | |
| 72-SPC-2815 | In distribution | |
| 72-OPC-2412 | In distribution | |
| 72-OTB-3212 | In distribution | |
| 72-CPC-2412-2C | In distribution | |
| 72-OPA-3609-2C | In distribution | |
| 72-SPB-3012 | In distribution | |
| 72-SPA-2607-2C | In distribution | |
| 72-CTB-2416 | In distribution | |
| 72-SPC-3215 | In distribution | |
| 72-STA-2212 | In distribution | |
| 72-CPB-2809-2C | In distribution | |
| 72-SPA-2411-2C | In distribution | |
| 72-STA-2210 | In distribution | |
| 72-STB-3216 | In distribution | |
| 72-SPD-2411 | In distribution | |
| 72-STD-2616 | In distribution | |
| 72-OTC-3211 | In distribution | |
| 72-OPB-2811-2C | In distribution | |
| 72-SPC-2813 | In distribution | |
| 72-SPD-2415 | In distribution | |
| 72-SPC-2812 | In distribution | |
| 72-CTB-3609 | In distribution | |
| 72-STA-2411 | In distribution | |
| 72-OTC-3616 | In distribution | |
| 72-STB-2809 | In distribution | |
| 72-STA-2806 | In distribution | |
| 72-STC-2215 | In distribution | |
| 72-CTC-3215 | In distribution | |
| 72-CTB-3608 | In distribution | |
| 72-CPB-3609 | In distribution | |
| 72-SPC-3011 | In distribution | |
| 72-SPD-2415-2C | In distribution | |
| 72-CTA-2411 | In distribution | |
| 72-OTC-3213 | In distribution | |
| 72-CPA-3207 | In distribution | |
| 72-CPC-2816-2C | In distribution | |
| 72-STA-2415 | In distribution | |
| 72-STA-3006 | In distribution | |
| 72-OPB-3212-2C | In distribution | |
| 72-OTA-2814 | In distribution | |
| 72-SPB-3214-2C | In distribution | |
| 72-OTB-3216 | In distribution | |
| 72-CPB-2807 | In distribution | |
| 72-CPC-2416-2C | In distribution | |
| 72-CPA-3613-2C | In distribution | |
| 72-OTB-3215 | In distribution | |
| 72-OTC-3210 | In distribution | |
| 72-OTA-2816 | In distribution | |
| 72-SPA-2812-2C | In distribution | |
| 72-SPD-2210-2C | In distribution | |
| 72-STC-2611 | In distribution | |
| 72-OTD-3615 | In distribution | |
| 72-SPA-2215-2C | In distribution | |
| 72-OPD-3614 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212075 | 2021-12-08 |
| K171657 | 2017-08-11 |
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.