Sovereign™ Spinal System
Spacer 78673022 SV PTC S 32X23X22 30D CP
3manufacturers in China registered for this device type
185catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K162680 |
| Record published | 2017-02-16 |
| Record revised | 2022-09-16 (version 9) |
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 23 to 42 mm; height 10 to 200 mm; length 20 to 42 mm; angle 8 to 12 °; depth 12 to 30 mm; outer diameter 5.5 to 6 mm; width 10.09 in; height 2.23 in |
| Distribution end date | 2026-03-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 79614210 | Width 32.0 mm | In distribution |
| 79615216 | Height 16.0 mm | In distribution |
| 79614820 | Width 32.0 mm | In distribution |
| 7967096 | In distribution | |
| 79616210 | Depth 30.0 mm | In distribution |
| 7960080 | In distribution | |
| 9010002053 | Height 20.0 mm | In distribution |
| 9010002092 | Height 24.0 mm | In distribution |
| 7980068 | In distribution | |
| 79616218 | Depth 30.0 mm | In distribution |
| 9010002071 | Height 18.0 mm | In distribution |
| 79614218 | Angle 12.0 ° | In distribution |
| 9010002018 | In distribution | |
| 7969002 | In distribution | |
| 9010002078 | Length 37.0 mm | In distribution |
| 9010002085 | Width 30.0 mm | In distribution |
| 79616214 | Width 42.0 mm | In distribution |
| 79615810 | Depth 27.0 mm | In distribution |
| 9010002062 | Length 32.0 mm | In distribution |
| 7969007 | In distribution | |
| 7969004 | In distribution | |
| 7976020 | Outer Diameter 6.0 mm | In distribution |
| 9010002058 | Length 32.0 mm | In distribution |
| 9010002070 | Height 16.0 mm | In distribution |
| 9010002059 | Length 32.0 mm | In distribution |
| 7967097 | In distribution | |
| 9010002060 | Width 23.0 mm | In distribution |
| 9010002088 | Length 42.0 mm | In distribution |
| 79616816 | Height 16.0 mm | In distribution |
| 79615220 | Depth 27.0 mm | In distribution |
| 79614214 | Width 32.0 mm | In distribution |
| 79616216 | Width 42.0 mm | In distribution |
| 7967041 | In distribution | |
| 7975525 | Length 25.0 mm | In distribution |
| 79614818 | Angle 8.0 ° | In distribution |
| 9010002068 | Length 37.0 mm | In distribution |
| 9010002074 | Width 27.0 mm | In distribution |
| 79616810 | Angle 8.0 ° | In distribution |
| 7975530 | Outer Diameter 5.5 mm | In distribution |
| 79615210 | Depth 27.0 mm | In distribution |
| 79616812 | Width 42.0 mm | In distribution |
| 9010002067 | Length 37.0 mm | In distribution |
| 9010002082 | Width 30.0 mm | In distribution |
| 9010002052 | Height 18.0 mm | In distribution |
| 79614216 | Height 16.0 mm | In distribution |
| 79614816 | Angle 8.0 ° | In distribution |
| 9010002055 | Height 16.0 mm | In distribution |
| 9010002084 | Height 22.0 mm | In distribution |
| 79614812 | Width 32.0 mm | In distribution |
| 9010002057 | Width 23.0 mm | In distribution |
| 79615218 | Width 37.0 mm | In distribution |
| 7980067 | In distribution | |
| 9010002051 | Height 16.0 mm | In distribution |
| 79616220 | Angle 12.0 ° | In distribution |
| 9010002076 | Length 37.0 mm | In distribution |
| 79615816 | Depth 27.0 mm | In distribution |
| 9010002066 | Height 16.0 mm | In distribution |
| 7975535 | Outer Diameter 5.5 mm | In distribution |
| 79614212 | Width 32.0 mm | In distribution |
| 9010002079 | Width 27.0 mm | In distribution |
| 9010002081 | Height 16.0 mm | In distribution |
| 7967095 | In distribution | |
| 9010002080 | Width 30.0 mm | In distribution |
| 79616820 | Depth 30.0 mm | In distribution |
| 9010002056 | Length 32.0 mm | In distribution |
| 79615820 | Height 20.0 mm | In distribution |
| 9010002073 | Height 22.0 mm | In distribution |
| 7976030 | Outer Diameter 6.0 mm | In distribution |
| 79616212 | Height 12.0 mm | In distribution |
| 7976035 | Outer Diameter 6.0 mm | In distribution |
| 9010002072 | Length 37.0 mm | In distribution |
| 79614810 | Depth 23.0 mm | In distribution |
| 7969000 | Width 10.09 in | In distribution |
| 9010002087 | Height 200.0 mm | In distribution |
| 9010002065 | Width 27.0 mm | In distribution |
| 7975520 | Outer Diameter 5.5 mm | In distribution |
| 9010002075 | Width 27.0 mm | In distribution |
| 79615814 | Depth 27.0 mm | In distribution |
| 9010002050 | Length 32.0 mm | In distribution |
| 9010002089 | Height 24.0 mm | In distribution |
| 7967098 | In distribution | |
| 9010002086 | Height 18.0 mm | In distribution |
| 9010002022 | In distribution | |
| 9010002061 | Height 20.0 mm | In distribution |
| 7969001 | In distribution | |
| 79615812 | Height 12.0 mm | In distribution |
| 79614814 | Depth 23.0 mm | In distribution |
| 9010002054 | Width 23.0 mm | In distribution |
| 79614220 | Width 32.0 mm | In distribution |
| 9010002063 | Length 32.0 mm | In distribution |
| 7969006 | In distribution | |
| 79615818 | Width 37.0 mm | In distribution |
| 7976025 | Outer Diameter 6.0 mm | In distribution |
| 9010002091 | Width 30.0 mm | In distribution |
| 79615212 | Depth 27.0 mm | In distribution |
| 7960081 | In distribution | |
| 9010002090 | Height 20.0 mm | In distribution |
| 9010002083 | Length 42.0 mm | In distribution |
| 79616818 | Height 18.0 mm | In distribution |
| 79616814 | Height 14.0 mm | In distribution |
| 9010002064 | Height 26.0 mm | In distribution |
| 79615214 | Angle 12.0 ° | In distribution |
| 9010002077 | Height 22.0 mm | In distribution |
| 9010002069 | Height 22.0 mm | In distribution |
| 9010002093 | Width 30.0 mm | In distribution |
| 78673022 | Length 32.0 mm | Withdrawn |
| 78672416 | Width 23.0 mm | Withdrawn |
| 78682418 | Length 37.0 mm | Withdrawn |
| 78681822 | Length 37.0 mm | Withdrawn |
| 78671220 | Width 23.0 mm | Withdrawn |
| 78683026 | Height 26.0 mm | Withdrawn |
| 78673024 | Height 24.0 mm | Withdrawn |
| 78692418 | Height 18.0 mm | Withdrawn |
| 78680820 | Height 20.0 mm | Withdrawn |
| 78691212 | Length 42.0 mm | Withdrawn |
| 78681214 | Height 14.0 mm | Withdrawn |
| 78690816 | Width 30.0 mm | Withdrawn |
| 78690820 | Height 20.0 mm | Withdrawn |
| 78683022 | Width 27.0 mm | Withdrawn |
| 78691820 | Width 30.0 mm | Withdrawn |
| 78681820 | Height 20.0 mm | Withdrawn |
| 78683020 | Height 20.0 mm | Withdrawn |
| 78673026 | Width 23.0 mm | Withdrawn |
| 78691818 | Height 18.0 mm | Withdrawn |
| 78672418 | Height 18.0 mm | Withdrawn |
| 78692422 | Height 22.0 mm | Withdrawn |
| 78693026 | Height 26.0 mm | Withdrawn |
| 78681212 | Width 27.0 mm | Withdrawn |
| 78693022 | Height 22.0 mm | Withdrawn |
| 78670810 | Width 23.0 mm | Withdrawn |
| 78682416 | Height 16.0 mm | Withdrawn |
| 78682422 | Height 22.0 mm | Withdrawn |
| 78673018 | Width 23.0 mm | Withdrawn |
| 78683024 | Height 24.0 mm | Withdrawn |
| 78691216 | Width 30.0 mm | Withdrawn |
| 78691210 | Height 10.0 mm | Withdrawn |
| 78671210 | Height 10.0 mm | Withdrawn |
| 78680818 | Width 27.0 mm | Withdrawn |
| 78673020 | Length 32.0 mm | Withdrawn |
| 78683018 | Length 37.0 mm | Withdrawn |
| 78670816 | Height 16.0 mm | Withdrawn |
| 78671214 | Width 23.0 mm | Withdrawn |
| 78671818 | Width 23.0 mm | Withdrawn |
| 78692416 | Length 42.0 mm | Withdrawn |
| 78681218 | Width 27.0 mm | Withdrawn |
| 78671216 | Length 32.0 mm | Withdrawn |
| 78690814 | Height 14.0 mm | Withdrawn |
| 78671820 | Height 20.0 mm | Withdrawn |
| 78692424 | Height 24.0 mm | Withdrawn |
| 78672420 | Length 32.0 mm | Withdrawn |
| 78670820 | Width 23.0 mm | Withdrawn |
| 78690810 | Length 42.0 mm | Withdrawn |
| 78671822 | Height 22.0 mm | Withdrawn |
| 78672422 | Height 22.0 mm | Withdrawn |
| 78682420 | Width 27.0 mm | Withdrawn |
| 78691822 | Width 30.0 mm | Withdrawn |
| 78672424 | Height 24.0 mm | Withdrawn |
| 78692420 | Height 20.0 mm | Withdrawn |
| 78671212 | Height 12.0 mm | Withdrawn |
| 78682424 | Width 27.0 mm | Withdrawn |
| 78681814 | Width 27.0 mm | Withdrawn |
| 78680816 | Width 27.0 mm | Withdrawn |
| 78693020 | Length 42.0 mm | Withdrawn |
| 78680810 | Width 27.0 mm | Withdrawn |
| 78670818 | Width 23.0 mm | Withdrawn |
| 78690818 | Height 18.0 mm | Withdrawn |
| 78691814 | Length 42.0 mm | Withdrawn |
| 78691816 | Width 30.0 mm | Withdrawn |
| 78670812 | Height 12.0 mm | Withdrawn |
| 78671814 | Width 23.0 mm | Withdrawn |
| 78681816 | Height 16.0 mm | Withdrawn |
| 78691218 | Length 42.0 mm | Withdrawn |
| 78681818 | Length 37.0 mm | Withdrawn |
| 78680812 | Width 27.0 mm | Withdrawn |
| 78680814 | Length 37.0 mm | Withdrawn |
| 78691214 | Height 14.0 mm | Withdrawn |
| 78681220 | Length 37.0 mm | Withdrawn |
| 78693024 | Height 24.0 mm | Withdrawn |
| 78691220 | Length 42.0 mm | Withdrawn |
| 78671218 | Width 23.0 mm | Withdrawn |
| 78670814 | Length 32.0 mm | Withdrawn |
| 78690812 | Height 12.0 mm | Withdrawn |
| 78671816 | Height 16.0 mm | Withdrawn |
| 78681216 | Length 37.0 mm | Withdrawn |
| 78681210 | Width 27.0 mm | Withdrawn |
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 |
|---|---|
| K121982 | 2012-07-26 |
| K110063 | 2011-10-04 |
| K091813 | 2009-11-17 |
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.