TrellOss®-A SA
TrellOss-A SA, Hyperlordotic, Implant Case
3manufacturers in China registered for this device type
245catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K202230 |
| Record published | 2022-09-29 |
| Record revised | 2025-07-14 (version 2) |
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 | Angle 8 to 25 °; width 32 to 40 mm; depth 24 to 30 mm; height 10 to 20 mm; outer diameter 5 to 5.5 mm; length 20 to 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 443H2014 | In distribution | |
| 431H0010 | In distribution | |
| 442H1414 | In distribution | |
| 447H0820 | In distribution | |
| 447H1414 | In distribution | |
| 449H3018 | In distribution | |
| 448H0814 | In distribution | |
| 448H1420 | In distribution | |
| 445H3018 | In distribution | |
| 424H0812 | Angle 8 ° | In distribution |
| 431H0004 | In distribution | |
| 446H1410 | In distribution | |
| 425H3020 | Angle 25 ° | In distribution |
| 444H1414 | In distribution | |
| 444H2020 | In distribution | |
| 430H2020 | Angle 20 ° | In distribution |
| 446H1420 | In distribution | |
| 444H1412 | In distribution | |
| 424H2012 | Depth 24 mm | In distribution |
| 446H2012 | In distribution | |
| 430H0810 | Angle 8 ° | In distribution |
| 447H2016 | In distribution | |
| 442H2016 | In distribution | |
| 448H0810 | In distribution | |
| 427H1418 | Angle 14 ° | In distribution |
| 444H0814 | In distribution | |
| 424H1410 | Width 32 mm | In distribution |
| 449H3014 | In distribution | |
| 443H1420 | In distribution | |
| 443H1414 | In distribution | |
| 427H0820 | Angle 8 ° | In distribution |
| 444H1408 | In distribution | |
| 400H1500 | In distribution | |
| 430H2014 | Angle 20 ° | In distribution |
| 442H0808 | In distribution | |
| 445H2720 | In distribution | |
| 447H1410 | In distribution | |
| 431H0011 | In distribution | |
| 447H2012 | In distribution | |
| 400H1100 | In distribution | |
| 445H2414 | In distribution | |
| 443H1408 | In distribution | |
| 448H1412 | In distribution | |
| 431H0016 | In distribution | |
| 427H2016 | Angle 20 ° | In distribution |
| 442H1408 | In distribution | |
| 442H1420 | In distribution | |
| 446H0818 | In distribution | |
| 448H1408 | In distribution | |
| 432H0004 | In distribution | |
| 425H2416 | Depth 24 mm | In distribution |
| 432H0008 | In distribution | |
| 442H2020 | In distribution | |
| 443H2018 | In distribution | |
| 430H1420 | Angle 14 ° | In distribution |
| 446H0808 | In distribution | |
| 430H1414 | Angle 14 ° | In distribution |
| 431H0008 | In distribution | |
| 448H2014 | In distribution | |
| 430H2016 | Angle 20 ° | In distribution |
| 444H0812 | In distribution | |
| 444H2016 | In distribution | |
| 445H2718 | In distribution | |
| 431H0015 | In distribution | |
| 431H0012 | In distribution | |
| 443H0812 | In distribution | |
| 424H2020 | Depth 24 mm | In distribution |
| 442H2018 | In distribution | |
| 443H0816 | In distribution | |
| 449H2418 | In distribution | |
| 448H1414 | In distribution | |
| 432H0002 | In distribution | |
| 448H1416 | In distribution | |
| 443H2016 | In distribution | |
| 442H0820 | In distribution | |
| 448H2018 | In distribution | |
| 400H5055 | In distribution | |
| 442H2014 | In distribution | |
| 405H5530 | Outer Diameter 5.5 mm | In distribution |
| 444H1410 | In distribution | |
| 400H1000 | In distribution | |
| 444H2018 | In distribution | |
| 447H0808 | In distribution | |
| 446H0810 | In distribution | |
| 447H0816 | In distribution | |
| 444H1420 | In distribution | |
| 443H0818 | In distribution | |
| 443H0820 | In distribution | |
| 431H0003 | In distribution | |
| 430H0818 | Angle 8 ° | In distribution |
| 449H3020 | In distribution | |
| 424H2018 | Depth 24 mm | In distribution |
| 425H3016 | Angle 25 ° | In distribution |
| 424H2014 | Depth 24 mm | In distribution |
| 400H1201 | In distribution | |
| 400H3040 | In distribution | |
| 432H0005 | In distribution | |
| 400H1101 | In distribution | |
| 443H0810 | In distribution | |
| 425H2718 | Width 36 mm | In distribution |
| 443H2020 | In distribution | |
| 427H1410 | Angle 14 ° | In distribution |
| 430H0820 | Angle 8 ° | In distribution |
| 425H2420 | Depth 24 mm | In distribution |
| 432H0010 | In distribution | |
| 446H1412 | In distribution | |
| 430H1412 | Angle 14 ° | In distribution |
| 424H0814 | Angle 8 ° | In distribution |
| 446H0820 | In distribution | |
| 447H0810 | In distribution | |
| 442H1410 | In distribution | |
| 424H1420 | Width 32 mm | In distribution |
| 443H0808 | In distribution | |
| 449H3016 | In distribution | |
| 432H0009 | In distribution | |
| 449H2716 | In distribution | |
| 444H1418 | In distribution | |
| 431H0005 | In distribution | |
| 432H0001 | In distribution | |
| 446H2014 | In distribution | |
| 424H0810 | Angle 8 ° | In distribution |
| 425H3014 | Angle 25 ° | In distribution |
| 449H2720 | In distribution | |
| 447H1416 | In distribution | |
| 446H2016 | In distribution | |
| 443H0814 | In distribution | |
| 431H0002 | In distribution | |
| 447H1412 | In distribution | |
| 425H2414 | Depth 24 mm | In distribution |
| 427H1416 | Angle 14 ° | In distribution |
| 424H0820 | Angle 8 ° | In distribution |
| 445H3016 | In distribution | |
| 432H0007 | In distribution | |
| 427H0816 | Angle 8 ° | In distribution |
| 400H1200 | In distribution | |
| 446H0816 | In distribution | |
| 448H2020 | In distribution | |
| 446H2018 | In distribution | |
| 427H2012 | Angle 20 ° | In distribution |
| 432H0003 | In distribution | |
| 447H0814 | In distribution | |
| 442H2012 | In distribution | |
| 442H1412 | In distribution | |
| 405H5525 | Outer Diameter 5.5 mm | In distribution |
| 424H1412 | Depth 24 mm | In distribution |
| 427H2018 | Angle 20 ° | In distribution |
| 405H5520 | Outer Diameter 5.5 mm | In distribution |
| 448H2016 | In distribution | |
| 442H0810 | In distribution | |
| 449H2416 | In distribution | |
| 447H2018 | In distribution | |
| 425H2716 | Width 36 mm | In distribution |
| 445H3020 | In distribution | |
| 430H0816 | Angle 8 ° | In distribution |
| 449H2718 | In distribution | |
| 445H2714 | In distribution | |
| 447H1420 | In distribution | |
| 448H0812 | In distribution | |
| 443H2012 | In distribution | |
| 427H1420 | Angle 14 ° | In distribution |
| 448H1410 | In distribution | |
| 400H1400 | In distribution | |
| 431H0007 | In distribution | |
| 430H1416 | Angle 14 ° | In distribution |
| 443H1412 | In distribution | |
| 442H1416 | In distribution | |
| 442H0814 | In distribution | |
| 405H5025 | Outer Diameter 5 mm | In distribution |
| 448H0808 | In distribution | |
| 424H1418 | Width 32 mm | In distribution |
| 447H0812 | In distribution | |
| 400H1300 | In distribution | |
| 445H2418 | In distribution | |
| 446H0812 | In distribution | |
| 424H2016 | Depth 24 mm | In distribution |
| 424H0816 | Angle 8 ° | In distribution |
| 449H2420 | In distribution | |
| 400H2432 | In distribution | |
| 400H1501 | In distribution | |
| 427H1412 | Angle 14 ° | In distribution |
| 443H1416 | In distribution | |
| 430H1418 | Angle 14 ° | In distribution |
| 427H0812 | Angle 8 ° | In distribution |
| 445H2420 | In distribution | |
| 430H0814 | Angle 8 ° | In distribution |
| 446H1408 | In distribution | |
| 448H0818 | In distribution | |
| 432H0006 | In distribution | |
| 425H3018 | Angle 25 ° | In distribution |
| 444H1416 | In distribution | |
| 445H2416 | In distribution | |
| 400H2000 | In distribution | |
| 442H0812 | In distribution | |
| 447H2014 | In distribution | |
| 447H2020 | In distribution | |
| 442H0818 | In distribution | |
| 430H1410 | Angle 14 ° | In distribution |
| 443H1410 | In distribution | |
| 448H1418 | In distribution | |
| 446H0814 | In distribution | |
| 405H5035 | Outer Diameter 5 mm | In distribution |
| 427H0814 | Angle 8 ° | In distribution |
| 446H2020 | In distribution | |
| 444H0818 | In distribution | |
| 444H0816 | In distribution | |
| 447H0818 | In distribution | |
| 444H2014 | In distribution | |
| 447H1418 | In distribution | |
| 444H0820 | In distribution | |
| 448H0816 | In distribution | |
| 400H2736 | In distribution | |
| 427H1414 | Angle 14 ° | In distribution |
| 405H5030 | Outer Diameter 5 mm | In distribution |
| 447H1408 | In distribution | |
| 424H1414 | Depth 24 mm | In distribution |
| 427H0818 | Angle 8 ° | In distribution |
| 424H0818 | Angle 8 ° | In distribution |
| 424H1416 | Depth 24 mm | In distribution |
| 400H2500 | In distribution | |
| 444H0808 | In distribution | |
| 449H2714 | In distribution | |
| 444H0810 | In distribution | |
| 432H0011 | In distribution | |
| 431H0009 | In distribution | |
| 405H5020 | Outer Diameter 5 mm | In distribution |
| 425H2720 | Width 36 mm | In distribution |
| 430H0812 | Angle 8 ° | In distribution |
| 427H0810 | Angle 8 ° | In distribution |
| 427H2020 | Angle 20 ° | In distribution |
| 405H5535 | Outer Diameter 5.5 mm | In distribution |
| 431H0001 | In distribution | |
| 425H2418 | Depth 24 mm | In distribution |
| 448H0820 | In distribution | |
| 443H1418 | In distribution | |
| 427H2014 | Angle 20 ° | In distribution |
| 445H3014 | In distribution | |
| 446H1418 | In distribution | |
| 446H1416 | In distribution | |
| 445H2716 | In distribution | |
| 430H2018 | Angle 20 ° | In distribution |
| 442H1418 | In distribution | |
| 442H0816 | In distribution | |
| 446H1414 | In distribution | |
| 425H2714 | Width 36 mm | In distribution |
| 449H2414 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202230 | 2020-12-15 |
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.