Shark Lumbar Spacer System
PLI,SPACER,SHARK,Ti,9,25X12,4 DEG
6manufacturers in China registered for this device type
34catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| K-MED Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 20 |
| Zhejiang Sorfa Life Science Research Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Xiamen Aquatown Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 5 |
Record
| Listed by | Choice Spine, LP |
|---|---|
| FDA product code | MPQ |
| Device type | Container, Specimen, Urine, Drugs Of Abuse, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3260 |
| 510(k) | K140142 |
| Record published | 2017-06-28 |
| 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 | Height 7 to 18 mm; length 22 to 28 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PT22-25124 | Height 12 mm | In distribution |
| PT22-28184 | Height 18 mm | In distribution |
| PT22-22164 | Height 16 mm | In distribution |
| PT22-28124 | Length 28 mm | In distribution |
| PP22-28134 | In distribution | |
| PP22-25174 | In distribution | |
| PP22-22114 | In distribution | |
| PP22-22084 | In distribution | |
| PT22-22104 | Height 10 mm | In distribution |
| PP22-25114 | In distribution | |
| PT22-25164 | Height 16 mm | In distribution |
| PT22-22144 | Length 22 mm | In distribution |
| PT22-25144 | Height 14 mm | In distribution |
| PT22-28164 | Height 16 mm | In distribution |
| PP22-28184 | In distribution | |
| PP22-22104 | In distribution | |
| PT22-28114 | Height 11 mm | In distribution |
| PT22-28104 | Length 28 mm | In distribution |
| PP22-22164 | In distribution | |
| PT22-22114 | Height 11 mm | In distribution |
| PT22-22084 | Length 22 mm | In distribution |
| PP22-22144 | In distribution | |
| PT22-25154 | Length 25 mm | In distribution |
| PT22-22124 | Length 22 mm | In distribution |
| PP22-25074 | In distribution | |
| PT22-28084 | Height 8 mm | In distribution |
| PT22-22174 | Height 17 mm | In distribution |
| PT22-25084 | Length 25 mm | In distribution |
| PP22-25154 | In distribution | |
| PT22-25174 | Length 25 mm | In distribution |
| PT22-22074 | Length 22 mm | In distribution |
| PT22-25104 | Length 25 mm | In distribution |
| PT22-28134 | Length 28 mm | In distribution |
| PP22-28094 | In distribution |
Same Product Code
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.