Arena-C®
Arena-C is a cervical interbody fusion range whose implanted spacer is made from PEEK. The spacer supports the interbody fusion site and is used with autogenous bone graft. Raised contours…
Arena-C is a cervical interbody fusion range whose implanted spacer is made from PEEK. The spacer supports the interbody fusion site and is used with autogenous bone graft.
Raised contours on the upper and lower surfaces help resist movement after implantation. Different implant heights accommodate anatomical variation, with the spacer serving the interbody role within the cervical construct.
Listed Item
Trial Spacer, Center Stop, Assembly, Lordotic, 11mm
Fusion Construct
The range is intended for a single cervical disc level from C2-C3 through C7-T1 and is used with supplemental cervical fixation, such as an anterior plate. A trial spacer belongs to the associated sizing equipment rather than the implanted spacer configuration described here.
7manufacturers in China registered for this device type
124catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Spinefrontier, Inc., United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K113518 |
| Record published | 2016-10-05 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 11 to 17 mm; height 5 to 12 mm; length 11 to 17 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-72015-09 | In distribution | |
| 11-72000-04 | In distribution | |
| 11-72061-11 | In distribution | |
| 01-72000-12 | Width 15 mm | In distribution |
| 11-72051-06 | In distribution | |
| 01-72038-10 | Length 11 mm | In distribution |
| 11-72061-07 | In distribution | |
| 11-72061-06 | In distribution | |
| 11-72043-07 | In distribution | |
| 01-72037-11 | Width 11 mm | In distribution |
| 01-72038-05 | Length 11 mm | In distribution |
| 01-72008-05 | Length 12 mm | In distribution |
| 11-72051-09 | In distribution | |
| 01-72037-07 | Width 11 mm | In distribution |
| 11-72061-12 | In distribution | |
| 11-72050-08 | In distribution | |
| 01-72007-08 | Height 8 mm | In distribution |
| 11-72010-05 | In distribution | |
| 01-72037-12 | Height 12 mm | In distribution |
| 11-72034-11 | In distribution | |
| 01-72007-09 | Length 15 mm | In distribution |
| 11-72033-08 | In distribution | |
| 11-72051-05 | In distribution | |
| 01-72001-07 | Width 15 mm | In distribution |
| 01-72007-12 | Length 15 mm | In distribution |
| 01-72001-11 | Height 11 mm | In distribution |
| 11-72061-09 | In distribution | |
| 11-72044-09 | In distribution | |
| 01-72038-11 | Height 11 mm | In distribution |
| 01-72007-07 | Height 7 mm | In distribution |
| 01-72008-08 | Length 12 mm | In distribution |
| 11-72010-07 | In distribution | |
| 01-72038-12 | Width 17 mm | In distribution |
| 01-72037-09 | Width 11 mm | In distribution |
| 11-72010-12 | In distribution | |
| 11-72043-12 | In distribution | |
| 01-72000-09 | Width 15 mm | In distribution |
| 11-72000-02 | In distribution | |
| 11-72015-06 | In distribution | |
| 01-72001-06 | Length 12 mm | In distribution |
| 01-72001-12 | Width 15 mm | In distribution |
| 01-72007-06 | Width 12 mm | In distribution |
| 11-72034-06 | In distribution | |
| 01-72000-07 | Width 15 mm | In distribution |
| 11-72044-07 | In distribution | |
| 01-72038-06 | Height 6 mm | In distribution |
| 11-72050-10 | In distribution | |
| 11-72033-12 | In distribution | |
| 11-72051-07 | In distribution | |
| 11-72015-12 | In distribution | |
| 11-72043-08 | In distribution | |
| 11-72000-03 | In distribution | |
| 11-72010-09 | In distribution | |
| 11-72010-06 | In distribution | |
| 01-72000-06 | Height 6 mm | In distribution |
| 11-72015-10 | In distribution | |
| 11-72043-06 | In distribution | |
| 11-72044-05 | In distribution | |
| 11-72051-11 | In distribution | |
| 11-72034-08 | In distribution | |
| 01-72000-08 | Height 8 mm | In distribution |
| 11-72015-07 | In distribution | |
| 11-72050-12 | In distribution | |
| 11-72043-05 | In distribution | |
| 11-72061-05 | In distribution | |
| 01-72007-05 | Width 12 mm | In distribution |
| 11-72033-11 | In distribution | |
| 11-72050-07 | In distribution | |
| 01-72000-10 | Width 15 mm | In distribution |
| 11-72034-09 | In distribution | |
| 01-72008-10 | Height 10 mm | In distribution |
| 11-72043-09 | In distribution | |
| 01-72001-10 | Length 12 mm | In distribution |
| 11-72051-10 | In distribution | |
| 11-72044-06 | In distribution | |
| 11-72010-08 | In distribution | |
| 11-72015-08 | In distribution | |
| 11-72044-10 | In distribution | |
| 11-72033-09 | In distribution | |
| 11-72010-10 | In distribution | |
| 11-72034-12 | In distribution | |
| 11-72010-11 | In distribution | |
| 01-72008-11 | Height 11 mm | In distribution |
| 01-72037-10 | Length 17 mm | In distribution |
| 11-72050-06 | In distribution | |
| 01-72008-07 | Height 7 mm | In distribution |
| 01-72038-09 | Width 17 mm | In distribution |
| 11-72033-06 | In distribution | |
| 11-72043-10 | In distribution | |
| 11-72015-05 | In distribution | |
| 01-72008-09 | Height 9 mm | In distribution |
| 11-72050-09 | In distribution | |
| 01-72007-10 | Width 12 mm | In distribution |
| 11-72043-11 | In distribution | |
| 11-72015-11 | In distribution | |
| 01-72000-11 | Length 12 mm | In distribution |
| 01-72038-07 | Length 11 mm | In distribution |
| 11-72034-10 | In distribution | |
| 01-72037-08 | Height 8 mm | In distribution |
| 11-72061-10 | In distribution | |
| 01-72001-09 | Length 12 mm | In distribution |
| 01-72001-08 | Height 8 mm | In distribution |
| 11-72000-01 | In distribution | |
| 11-72033-05 | In distribution | |
| 11-72033-07 | In distribution | |
| 01-72000-05 | Height 5 mm | In distribution |
| 11-72044-12 | In distribution | |
| 01-72008-06 | Height 6 mm | In distribution |
| 11-72044-11 | In distribution | |
| 01-72037-06 | Height 6 mm | In distribution |
| 11-72050-11 | In distribution | |
| 11-72051-12 | In distribution | |
| 11-72033-10 | In distribution | |
| 11-72034-07 | In distribution | |
| 01-72038-08 | Length 11 mm | In distribution |
| 11-72034-05 | In distribution | |
| 11-72050-05 | In distribution | |
| 11-72044-08 | In distribution | |
| 01-72001-05 | Length 12 mm | In distribution |
| 01-72037-05 | Length 17 mm | In distribution |
| 11-72061-08 | In distribution | |
| 01-72007-11 | Height 11 mm | In distribution |
| 11-72051-08 | In distribution | |
| 01-72008-12 | Width 15 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141333 | 2014-11-25 |
| K142026 | 2014-10-20 |
| K141337 | 2014-09-08 |
| K113518 | 2012-02-16 |
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.