Twist
6.5mm Twist AP SST Suture Anchor
2manufacturers in China registered for this device type
12catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Parcus Medical, LLC, United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K183501 |
| Record published | 2020-10-22 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 4.5 to 6.5 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11360 | Outer Diameter 6.5 mm | In distribution |
| 11125 | Outer Diameter 4.5 mm | In distribution |
| 10927 | Outer Diameter 5.5 mm | In distribution |
| 11359 | Outer Diameter 6.5 mm | In distribution |
| 11358 | Outer Diameter 5.5 mm | In distribution |
| 11357 | Outer Diameter 5.5 mm | In distribution |
| 11126 | Outer Diameter 5.5 mm | In distribution |
| 10927T | Outer Diameter 5.5 mm | In distribution |
| 11127 | Outer Diameter 6.5 mm | In distribution |
| 10798T | Outer Diameter 6.5 mm | In distribution |
| 10797T | Outer Diameter 5.5 mm | In distribution |
| 10796T | Outer Diameter 4.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| Fix2Lock | Osteonic Co., Ltd. | 118 |
| Delta | Stryker Leibinger Gmbh & Co. KG | 110 |
| Reunite Screw System | Biomet Orthopedics | 85 |
| ComposiTCP | S.B.M | 61 |
| ActivaScrew™ Interference | Bioretec Ltd. | 54 |
| Ligafix | S.B.M | 40 |
| Twinfix | Smith & Nephew, Inc. | 28 |
| Biosure | Smith & Nephew, Inc. | 27 |
| TorqLoc Interference | Bioretec Ltd. | 27 |
| FiberFIX | Nanova BIO Materials Inc | 25 |
| AlphaVent | Stryker GmbH | 23 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232513 | 2023-09-18 |
| K192824 | 2019-11-02 |
| K183501 | 2019-03-15 |
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.