ROI-C
Black finish on ROI-C Implant Holder and lateral depth stop
5manufacturers in China registered for this device type
197catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Ldr Spine USA, United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2017-03-24 |
| Record revised | 2025-01-03 (version 11) |
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 | Height 4.5 to 10 mm; width 14 to 17 mm; depth 12 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SI-ROIC-0023 | Height 5 mm | In distribution |
| SI-ROIC-0015 | Height 4.5 mm | In distribution |
| MC9040R | Depth 14 mm | In distribution |
| MC9001R | In distribution | |
| MC9037R | Depth 14 mm | In distribution |
| CMC1344P | Height 8 mm | In distribution |
| MC9112R | Height 5 mm | In distribution |
| MC1433P | Width 17 mm | In distribution |
| MC9119R | Depth 14 mm | In distribution |
| CMC1441P | Width 14 mm | In distribution |
| MC9036R | Height 9 mm | In distribution |
| MC9118R | Height 5 mm | In distribution |
| CMC1435P | Width 17 mm | In distribution |
| MC9107R | Depth 12 mm | In distribution |
| MC9101R | Depth 12 mm | In distribution |
| MC9003R | In distribution | |
| MC9116R | Height 9 mm | In distribution |
| MC9041R | Height 7 mm | In distribution |
| CMC1351P | Height 5 mm | In distribution |
| CMC1314P | Height 8 mm | In distribution |
| SI-ROIC-0114 | In distribution | |
| SI-ROIC-0113 | In distribution | |
| CMC1434P | Height 8 mm | In distribution |
| MC9044R | Depth 14 mm | In distribution |
| MC9043R | Height 9 mm | In distribution |
| SI-ROIC-0009 | Height 5 mm | In distribution |
| CMC1411P | Height 5 mm | In distribution |
| MC9103R | Depth 12 mm | In distribution |
| CMC1346P | Height 10 mm | In distribution |
| CMC1323P | Height 7 mm | In distribution |
| MC9109R | Depth 12 mm | In distribution |
| CMC1334P | Width 17 mm | In distribution |
| MC9093R | In distribution | |
| SI-ROIC-0038 | In distribution | |
| CMC1354P | Width 15.5 mm | In distribution |
| MC9030R | Height 10 mm | In distribution |
| MC9034R | Height 7 mm | In distribution |
| CMC1444P | Height 8 mm | In distribution |
| MC9025R | Depth 14 mm | In distribution |
| CMC1326P | Height 10 mm | In distribution |
| CMC1413P | Height 7 mm | In distribution |
| MC9102R | Height 7 mm | In distribution |
| CMC1414P | Width 14 mm | In distribution |
| MC9122R | Height 9 mm | In distribution |
| SI-ROIC-0019 | Height 8 mm | In distribution |
| MC9105R | Depth 12 mm | In distribution |
| MC9039R | Height 5 mm | In distribution |
| MC1453P | Width 15.5 mm | In distribution |
| CMC1424P | Width 15.5 mm | In distribution |
| SI-ROIC-0018 | Depth 14 mm | In distribution |
| SI-ROIC-0032 | Depth 14 mm | In distribution |
| CMC1422P | Width 15.5 mm | In distribution |
| CMC1345P | Width 14 mm | In distribution |
| SI-ROIC-0017 | Height 6 mm | In distribution |
| MC9013R | Depth 12 mm | In distribution |
| CMC1432P | Width 17 mm | In distribution |
| CMC1320P | Width 15.5 mm | In distribution |
| CMC1426P | Width 15.5 mm | In distribution |
| SI-ROIC-0031 | Height 7 mm | In distribution |
| MC9092R | In distribution | |
| MC9024R | Height 4.5 mm | In distribution |
| MC9097R | In distribution | |
| CMC1443P | Width 14 mm | In distribution |
| CMC1340P | Height 4.5 mm | In distribution |
| MC9021R | Depth 12 mm | In distribution |
| MC1446P | Width 14 mm | In distribution |
| SI-ROIC-0003 | Height 6 mm | In distribution |
| SI-ROIC-0011 | Height 7 mm | In distribution |
| CMC1311P | Width 14 mm | In distribution |
| MC1421P | Width 15.5 mm | In distribution |
| MC9095R-S | In distribution | |
| MC9020R | Height 7 mm | In distribution |
| MC9019R | Depth 12 mm | In distribution |
| CMC1425P | Height 9 mm | In distribution |
| MC1442P | Width 14 mm | In distribution |
| CMC1341P | Width 14 mm | In distribution |
| CMC1310P | Height 4.5 mm | In distribution |
| MC1435P | Width 17 mm | In distribution |
| CMC1342P | Height 6 mm | In distribution |
| MC9014R | Height 8 mm | In distribution |
| MC9032R | Height 5 mm | In distribution |
| MC9127R | Depth 14 mm | In distribution |
| CMC1355P | Height 9 mm | In distribution |
| MC1434P | Width 17 mm | In distribution |
| MC1441P | Width 14 mm | In distribution |
| MC9029R | Depth 14 mm | In distribution |
| CMC1331P | Height 5 mm | In distribution |
| CMC1436P | Height 10 mm | In distribution |
| MC9121R | Depth 14 mm | In distribution |
| SI-ROIC-0002 | Depth 12 mm | In distribution |
| MC9042R | Depth 14 mm | In distribution |
| MC9104R | Height 9 mm | In distribution |
| SI-ROIC-0117 | Depth 12 mm | In distribution |
| MC9124R | Height 5 mm | In distribution |
| MC1426P | Width 15.5 mm | In distribution |
| MC9023R | Depth 12 mm | In distribution |
| MC9035R | Depth 14 mm | In distribution |
| CMC1350P | Width 15.5 mm | In distribution |
| SI-ROIC-0012 | Depth 12 mm | In distribution |
| MC9113R | Depth 14 mm | In distribution |
| MC9114R | Height 7 mm | In distribution |
| CMC1324P | Width 15.5 mm | In distribution |
| CMC1352P | Width 15.5 mm | In distribution |
| MC9117R | Depth 14 mm | In distribution |
| CMC1442P | Height 6 mm | In distribution |
| MC9108R | Height 7 mm | In distribution |
| SI-ROIC-0001 | Height 4.5 mm | In distribution |
| MC9017R | Depth 12 mm | In distribution |
| SI-ROIC-0016 | Depth 14 mm | In distribution |
| CMC1332P | Width 17 mm | In distribution |
| SI-ROIC-0040 | In distribution | |
| MC1431P | Width 17 mm | In distribution |
| SI-ROIC-0052 | In distribution | |
| MC9123R | Depth 14 mm | In distribution |
| CMC1343P | Width 14 mm | In distribution |
| MC1456P | Width 15.5 mm | In distribution |
| MC9094R | In distribution | |
| SI-ROIC-0022 | Depth 14 mm | In distribution |
| CMC1313P | Width 14 mm | In distribution |
| MC9096R-S | In distribution | |
| CMC1322P | Width 15.5 mm | In distribution |
| CMC1316P | Height 10 mm | In distribution |
| MC9004R | In distribution | |
| SI-ROIC-0116 | Height 5 mm | In distribution |
| MC9011R | Depth 12 mm | In distribution |
| MC9010R | Height 4.5 mm | In distribution |
| MC9002R | In distribution | |
| MC9022R | Height 9 mm | In distribution |
| MC1445P | Width 14 mm | In distribution |
| SI-ROIC-0036 | In distribution | |
| MC1452P | Width 15.5 mm | In distribution |
| CMC1325P | Width 15.5 mm | In distribution |
| CMC1454P | Height 8 mm | In distribution |
| MC9031R | Depth 14 mm | In distribution |
| SI-ROIC-0115 | In distribution | |
| MC9115R | Depth 14 mm | In distribution |
| SI-ROIC-0111 | In distribution | |
| CMC1451P | Width 15.5 mm | In distribution |
| MC9026R | Height 6 mm | In distribution |
| MC9015R | Depth 12 mm | In distribution |
| SI-ROIC-0026 | Depth 14 mm | In distribution |
| MC9110R | Height 9 mm | In distribution |
| MC9028R | Height 8 mm | In distribution |
| MC9106R | Height 5 mm | In distribution |
| MC1451P | Width 15.5 mm | In distribution |
| CMC1335P | Width 17 mm | In distribution |
| CMC1423P | Height 7 mm | In distribution |
| SI-ROIC-0041 | In distribution | |
| SI-ROIC-0025 | Height 7 mm | In distribution |
| MC9128R | Height 9 mm | In distribution |
| MC9126R | Height 7 mm | In distribution |
| MC9111R | Depth 12 mm | In distribution |
| CMC1446P | Height 10 mm | In distribution |
| MC1444P | Width 14 mm | In distribution |
| MC9120R | Height 7 mm | In distribution |
| CMC1416P | Width 14 mm | In distribution |
| MC1454P | Width 15.5 mm | In distribution |
| SI-ROIC-0008 | Depth 12 mm | In distribution |
| MC9016R | Height 10 mm | In distribution |
| CMC1321P | Height 5 mm | In distribution |
| SI-ROIC-0010 | Depth 12 mm | In distribution |
| SI-ROIC-0112 | In distribution | |
| MC9100R | Height 5 mm | In distribution |
| CMC1333P | Height 7 mm | In distribution |
| MC1425P | Width 15.5 mm | In distribution |
| CMC1445P | Width 14 mm | In distribution |
| CMC1356P | Width 15.5 mm | In distribution |
| CMC1415P | Height 9 mm | In distribution |
| MC1436P | Width 17 mm | In distribution |
| MC1423P | Width 15.5 mm | In distribution |
| CMC1315P | Width 14 mm | In distribution |
| SI-ROIC-0024 | Depth 14 mm | In distribution |
| CMC1353P | Height 7 mm | In distribution |
| CMC1412P | Width 14 mm | In distribution |
| CMC1312P | Height 6 mm | In distribution |
| MC9012R | Height 6 mm | In distribution |
| SI-ROIC-0037 | In distribution | |
| CMC1455P | Width 15.5 mm | In distribution |
| CMC1431P | Height 5 mm | In distribution |
| MC9091R | In distribution | |
| SI-ROIC-0004 | Depth 12 mm | In distribution |
| MC9089R | In distribution | |
| MC9033R | Depth 14 mm | In distribution |
| CMC1456P | Height 10 mm | In distribution |
| SI-ROIC-0039 | In distribution | |
| CMC1452P | Height 6 mm | In distribution |
| CMC1453P | Width 15.5 mm | In distribution |
| SI-ROIC-0005 | Height 8 mm | In distribution |
| CMC1336P | Height 10 mm | In distribution |
| CMC1421P | Height 5 mm | In distribution |
| MC9027R | Depth 14 mm | In distribution |
| SI-ROIC-0029 | Height 5 mm | In distribution |
| MC9018R | Height 5 mm | In distribution |
| MC1443P | Width 14 mm | In distribution |
| MC9129R | Depth 14 mm | In distribution |
| MC9125R | Depth 14 mm | In distribution |
| SI-ROIC-0030 | Depth 14 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151934 | 2015-12-07 |
| K150765 | 2015-09-17 |
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.