ORIO-3D Cage System
ORIO-3D Trabecular Ti P-TLIF Cage, Trapezoidal, 9mm Wide, 12 x 28mm, 5 deg.
3manufacturers in China registered for this device type
90catalogue numbers in this listing
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 | Spinecraft 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 | Specification developer, Manufacturer |
| 510(k) | K253260 |
| Record published | 2026-05-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SP-CP-200-08 | In distribution | |
| SP-CP-400-06 | In distribution | |
| SP-LP-CT06-1031 | In distribution | |
| SP-CP-315-08 | In distribution | |
| SP-LP-CT12-0931 | In distribution | |
| SP-LPS-A215-16 | In distribution | |
| SP-LP-ST06-1226 | In distribution | |
| SP-LPS-A110-10 | In distribution | |
| SP-LP-CT06-1231 | In distribution | |
| SP-LP-PTT5-0824 | In distribution | |
| SP-LPS-A320-22 | In distribution | |
| SP-CP-415-06 | In distribution | |
| SP-LP-PTT5-1228 | In distribution | |
| SP-LPS-A210-12 | In distribution | |
| SP-CP-315-07 | In distribution | |
| SP-LP-PTT5-1428 | In distribution | |
| SP-CP-215-08 | In distribution | |
| SP-LP-PTT5-1628 | In distribution | |
| SP-CP-107-05 | In distribution | |
| SP-CP-111-09 | In distribution | |
| SP-CP-407-08 | In distribution | |
| SP-CP-407-10 | In distribution | |
| SP-LPS-A215-20 | In distribution | |
| SP-CP-415-08 | In distribution | |
| SP-LP-ST12-1426 | In distribution | |
| SP-LP-CT06-1331 | In distribution | |
| SP-LP-PT08-1426 | In distribution | |
| SP-LPS-A120-16 | In distribution | |
| SP-LP-ST06-0826 | In distribution | |
| SP-LP-ST06-0828 | In distribution | |
| SP-CP-111-05 | In distribution | |
| SP-CP-400-08 | In distribution | |
| SP-LP-CT06-1029 | In distribution | |
| SP-LP-PTT5-1226 | In distribution | |
| SP-LP-PT05-1624 | In distribution | |
| SP-CP-115-06 | In distribution | |
| SP-LP-ST12-1024 | In distribution | |
| SP-CP-200-09 | In distribution | |
| SP-LP-PT08-0822 | In distribution | |
| SP-CP-200-06 | In distribution | |
| SP-LP-PTT5-1026 | In distribution | |
| SP-LP-PTT5-1426 | In distribution | |
| SP-LPS-A325-24 | In distribution | |
| SP-CP-315-10 | In distribution | |
| SP-LP-ST06-0924 | In distribution | |
| SP-LP-ST06-1128 | In distribution | |
| SP-CP-100-06 | In distribution | |
| SP-LPS-A110-14 | In distribution | |
| SP-CP-200-10 | In distribution | |
| SP-LP-CT12-1229 | In distribution | |
| SP-LP-PTT5-1224 | In distribution | |
| SP-LP-PTT5-1024 | In distribution | |
| SP-LPS-A325-22 | In distribution | |
| SP-LP-PT08-1026 | In distribution | |
| SP-CP-407-07 | In distribution | |
| SP-CP-211-09 | In distribution | |
| SP-LP-PT08-1022 | In distribution | |
| SP-LP-CT12-1231 | In distribution | |
| SP-CP-115-09 | In distribution | |
| SP-CP-215-07 | In distribution | |
| SP-CP-207-10 | In distribution | |
| SP-CP-207-09 | In distribution | |
| SP-LPS-A215-18 | In distribution | |
| SP-LP-CT12-1029 | In distribution | |
| SP-CP-411-10 | In distribution | |
| SP-LPS-A210-14 | In distribution | |
| SP-LPS-A115-16 | In distribution | |
| SP-LPS-A315-20 | In distribution | |
| SP-LP-PTT5-1028 | In distribution | |
| SP-CP-215-06 | In distribution | |
| SP-LP-PT05-1424 | In distribution | |
| SP-CP-411-07 | In distribution | |
| SP-LP-ST06-1024 | In distribution | |
| SP-CP-311-08 | In distribution | |
| SP-LPS-A210-10 | In distribution | |
| SP-LP-CT06-1229 | In distribution | |
| SP-LP-PT05-1024 | In distribution | |
| SP-LP-CT12-1129 | In distribution | |
| SP-CP-315-09 | In distribution | |
| SP-LP-ST06-0926 | In distribution | |
| SP-LP-PT08-1622 | In distribution | |
| SP-LPS-A310-18 | In distribution | |
| SP-CP-415-10 | In distribution | |
| SP-LP-ST06-0824 | In distribution | |
| SP-CP-211-07 | In distribution | |
| SP-CP-211-06 | In distribution | |
| SP-CP-315-05 | In distribution | |
| SP-LP-PTT5-0828 | In distribution | |
| SP-CP-411-06 | In distribution | |
| SP-LP-CT06-0829 | 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
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.