Fix2Lock
Biocomposite Healmax Medial Anchor '5.25' 2Line(Teleflex)(Tape USP#5)(White/Blue)(USP#2)(White/Black)
2manufacturers in China registered for this device type
118catalogue numbers in this listing
4510(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 | Osteonic Co., Ltd., South Korea |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K202806 |
| Record published | 2021-07-05 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BHA-4820-2150 | In distribution | |
| BMA-5519-3240 | In distribution | |
| BLA-4750-1130 | In distribution | |
| BHA-5320-3220 | In distribution | |
| BIS-2110-1130 | In distribution | |
| BMA-4518-2370 | In distribution | |
| BMA-5519-1310 | In distribution | |
| BHA-5320-3240 | In distribution | |
| BIS-2110-1730 | In distribution | |
| BHA-4820-3230 | In distribution | |
| BIS-2610-2190 | In distribution | |
| BMA-4518-2150 | In distribution | |
| BMA-4518-3230 | In distribution | |
| BPH-4521-1120 | In distribution | |
| BPH-5021-1120 | In distribution | |
| BHA-4820-3240 | In distribution | |
| BMA-4518-3440 | In distribution | |
| BHA-5320-2170 | In distribution | |
| BIS-2110-2740 | In distribution | |
| BMA-5519-2340 | In distribution | |
| BMA-4518-3460 | In distribution | |
| BMA-4518-3450 | In distribution | |
| BIS-2610-2740 | In distribution | |
| BMA-5519-2180 | In distribution | |
| BMA-4518-2380 | In distribution | |
| BHA-4820-2190 | In distribution | |
| BLA-4750-1120 | In distribution | |
| BMA-5519-3230 | In distribution | |
| BIS-2610-1140 | In distribution | |
| BMA-5519-2360 | In distribution | |
| BMA-5519-2160 | In distribution | |
| BHA-5320-2180 | In distribution | |
| BIS-2610-1130 | In distribution | |
| BIS-2110-2180 | In distribution | |
| BMA-4518-3540 | In distribution | |
| BPH-4521-1030 | In distribution | |
| BMA-4518-2170 | In distribution | |
| BHA-4820-2180 | In distribution | |
| BMA-4518-3430 | In distribution | |
| BMA-5519-2370 | In distribution | |
| BMA-4518-1310 | In distribution | |
| BMA-5519-2350 | In distribution | |
| BPH-5021-1110 | In distribution | |
| BHA-5320-2160 | In distribution | |
| BMA-4518-1300 | In distribution | |
| BPH-5021-1140 | In distribution | |
| BLA-4722-1140 | In distribution | |
| BIS-2110-1710 | In distribution | |
| BIS-2110-2200 | In distribution | |
| BMA-5519-3540 | In distribution | |
| BHA-5320-2520 | In distribution | |
| BHA-5320-2150 | In distribution | |
| BLA-4722-1110 | In distribution | |
| BPH-4521-1130 | In distribution | |
| BIS-2110-1140 | In distribution | |
| BHA-5320-2200 | In distribution | |
| BPH-4521-1110 | In distribution | |
| BMA-5519-3430 | In distribution | |
| BHA-5320-3210 | In distribution | |
| BIS-2110-2190 | In distribution | |
| BMA-5519-3450 | In distribution | |
| BLA-4722-1120 | In distribution | |
| BMA-5519-3490 | In distribution | |
| BMA-4518-2330 | In distribution | |
| BIS-2110-1720 | In distribution | |
| BHA-5320-1310 | In distribution | |
| BIS-2610-2180 | In distribution | |
| BIS-2610-1730 | In distribution | |
| BMA-5519-3550 | In distribution | |
| BHA-4820-2170 | In distribution | |
| BMA-5519-3210 | In distribution | |
| BLA-47-21A | In distribution | |
| BMA-5519-2190 | In distribution | |
| BIS-2610-1710 | In distribution | |
| BLA-4750-1140 | In distribution | |
| BPH-5021-1130 | In distribution | |
| BHA-5320-2190 | In distribution | |
| BMA-4518-3480 | In distribution | |
| BMA-5519-1300 | In distribution | |
| BIS-2610-1720 | In distribution | |
| BPL-4750-1030 | In distribution | |
| BHA-4820-2200 | In distribution | |
| BMA-5519-3220 | In distribution | |
| BMA-5519-2150 | In distribution | |
| BIS-2610-1120 | In distribution | |
| BIS-2610-2200 | In distribution | |
| BHA-5320-2380 | In distribution | |
| BMA-4518-3550 | In distribution | |
| BMA-4518-2160 | In distribution | |
| BMA-5519-3440 | In distribution | |
| BMA-5519-3480 | In distribution | |
| BMA-4518-2190 | In distribution | |
| BLA-4722-1030 | In distribution | |
| BLA-4750-1110 | In distribution | |
| BMA-4518-2520 | In distribution | |
| BHA-5320-3230 | In distribution | |
| BMA-4518-2350 | In distribution | |
| BHA-4820-2160 | In distribution | |
| BHA-4820-3210 | In distribution | |
| BMA-4518-3210 | In distribution | |
| BLA-4750-BC225-1 | In distribution | |
| BMA-4518-3220 | In distribution | |
| BMA-4518-2340 | In distribution | |
| BPH-4521-1140 | In distribution | |
| BMA-4518-3490 | In distribution | |
| BLA-4722-1130 | In distribution | |
| BIS-2110-1120 | In distribution | |
| BMA-5519-3460 | In distribution | |
| BHA-4820-3220 | In distribution | |
| BMA-5519-2330 | In distribution | |
| BMA-5519-2200 | In distribution | |
| BMA-4518-2360 | In distribution | |
| BMA-4518-2180 | In distribution | |
| BMA-5519-2170 | In distribution | |
| BMA-4518-2200 | In distribution | |
| BMA-5519-2520 | In distribution | |
| BPH-5021-1030 | In distribution | |
| BMA-4518-3240 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 545 |
| 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 |
| Twist AP Suture Anchors | Parcus Medical, LLC | 17 |
Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243467 | 2024-12-03 |
| K231326 | 2023-05-31 |
| K210122 | 2021-08-27 |
| K202806 | 2021-06-17 |
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.