Perimeter® C Spinal System
Spacr X1214545 PER C TI Ster 6D 11X15X13
7manufacturers in China registered for this device type
48catalogue numbers in this listing
2510(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 | Medtronic Sofamor Danek, 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) | K132584 |
| Record published | 2015-09-02 |
| Record revised | 2024-09-11 (version 5) |
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 |
| Sizes | Width 13 to 15 mm; length 12 to 13 mm; height 5 to 12 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0312077 | Width 13.0 mm | In distribution |
| X1214545 | Height 11.0 mm | In distribution |
| X0312079 | Height 6.0 mm | In distribution |
| 6360253 | 12mm x 15mm x 13mm | In distribution |
| 6360132 | 11mm x 13mm x 12mm | In distribution |
| X0312080 | Length 13.0 mm | In distribution |
| X0312070 | Width 13.0 mm | In distribution |
| 6360753 | 7mm x 15mm x 13mm | In distribution |
| X0312085 | Length 13.0 mm | In distribution |
| X1214534 | Width 13.0 mm | In distribution |
| 6360553 | 5mm x 15mm x 13mm | In distribution |
| X1214540 | Height 6.0 mm | In distribution |
| X1214538 | Length 12.0 mm | In distribution |
| X1214539 | Width 15.0 mm | In distribution |
| X1214544 | Width 15.0 mm | In distribution |
| 6360832 | 8mm x 13mm x 12mm | In distribution |
| X0312083 | Length 13.0 mm | In distribution |
| X1214531 | Width 13.0 mm | In distribution |
| X1214533 | Height 7.0 mm | In distribution |
| X1214542 | Height 8.0 mm | In distribution |
| X0312078 | Height 5.0 mm | In distribution |
| 6360232 | 12mm x 13mm x 12mm | In distribution |
| 6360853 | 8mm x 15mm x 13mm | In distribution |
| 6360632 | 6mm x 13mm x 12mm | In distribution |
| X0312074 | Width 13.0 mm | In distribution |
| X0312082 | Width 15.0 mm | In distribution |
| 6360053 | 10mm x 15mm x 13mm | In distribution |
| X1214546 | Height 12.0 mm | In distribution |
| 6360953 | 9mm x 15mm x 13mm | In distribution |
| X1214535 | Width 13.0 mm | In distribution |
| X0312081 | Height 8.0 mm | In distribution |
| X1214537 | Length 12.0 mm | In distribution |
| X0312072 | Length 12.0 mm | In distribution |
| X1214541 | Width 15.0 mm | In distribution |
| 6360653 | 6mm x 15mm x 13mm | In distribution |
| X0312084 | Length 13.0 mm | In distribution |
| X0312073 | Height 8.0 mm | In distribution |
| X1214532 | Length 12.0 mm | In distribution |
| X0312075 | Height 10.0 mm | In distribution |
| 6360153 | 11mm x 15mm x 13mm | In distribution |
| X1214543 | Height 9.0 mm | In distribution |
| 6360532 | 5mm x 13mm x 12mm | In distribution |
| 6360932 | 9mm x 13mm x 12mm | In distribution |
| 6360732 | 7mm x 13mm x 12mm | In distribution |
| X1214536 | Length 12.0 mm | In distribution |
| X0312071 | Width 13.0 mm | In distribution |
| 6360032 | 10mm x 13mm x 12mm | In distribution |
| X0312076 | Length 12.0 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 |
|---|---|
| K153373 | 2016-01-19 |
| K100214 | 2010-06-25 |
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.