ANCHORMAN is a cortical tibial ligament fixation device. It consists of a sterile, double pouched Polyether ether ketone (PEEK) loop with two petals which rest on the cortical bone of the…
ANCHORMAN is a cortical tibial ligament fixation device. It consists of a sterile, double pouched Polyether ether ketone (PEEK) loop with two petals which rest on the cortical bone of the tibia
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Anchorman | Listed by | Summit Medical LLC, United States |
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K170388 |
| Record published | 2018-12-21 |
| Record revised | 2022-12-08 (version 4) |
Specifications
Specifications | MRI safety | MR Safe |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in the original packaging away from direct sunlight |
| Distribution end date | 2022-10-07 |
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.