Reunite Screw System
85 catalogue numbers from 348187, listed by Biomet Orthopedics, United States, under Fastener, Fixation, Biodegradable, Soft Tissue. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
85catalogue numbers in this listing
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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MAI |
| Device type | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K992301 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 348187 | 3.5 MM 34 MM FULL THREAD | In distribution |
| 348220 | 3.2 MM 70 MM | In distribution |
| 948847 | 4 MM 46 MM | In distribution |
| 348470 | 5.0 MM 70 MM PARTITAL THREAD | In distribution |
| 348176 | 3.5 MM 24 MM FULL THREAD | In distribution |
| 948504 | 2.5 MM 13 MM | In distribution |
| 348509 | 2.5 MM 23 MM | In distribution |
| 948181 | 3.5 MM 28 MM FULL THREAD | In distribution |
| 348184 | 3.5 MM 32 MM FULL THREAD | In distribution |
| 348203 | 1.5 MM 60 MM | In distribution |
| 948842 | 4 MM 42 MM FULL THREAD | In distribution |
| 948162 | 3.5 MM 10 MM FULL THREAD | In distribution |
| 348182 | 3.5 MM 30 MM FULL THREAD | In distribution |
| 348165 | 3.5 MM 12 MM FULL THREAD | In distribution |
| 948164 | 3.5 MM 12 MM FULL THREAD | In distribution |
| 948177 | 3.5 MM 24 MM FULL THREAD | In distribution |
| 348201 | 1.5 MM 20 MM | In distribution |
| 948106 | 2.8 MM 23 MM | In distribution |
| 348820 | 4 MM 20 MM | In distribution |
| 348111 | 2.8 MM 33 MM | In distribution |
| 348491 | 2.0 MM 7 MM | In distribution |
| 948185 | 3.5 MM 32 MM FULL THREAD | In distribution |
| 948820 | 4 MM 20 MM FULL THREAD | In distribution |
| 948843 | 4 MM 42 MM | In distribution |
| 948846 | 4 MM 46 MM FULL THREAD | In distribution |
| 948179 | 3.5 MM 26 MM FULL THREAD | In distribution |
| 348471 | 5.0 MM 70 MM PARTITAL THREAD | In distribution |
| 948163 | 3.5 MM 10 MM FULL THREAD | In distribution |
| 948109 | 2.8 MM 29 MM | In distribution |
| 348206 | 2.0 MM 25 MM | In distribution |
| 948108 | 2.8 MM 27 MM | In distribution |
| 948107 | 2.8 MM 25 MM | In distribution |
| 948187 | 3.5 MM 34 MM FULL THREAD | In distribution |
| 948168 | 3.5 MM 16 MM FULL THREAD | In distribution |
| 948165 | 3.5 MM 12 MM FULL THREAD | In distribution |
| 948190 | 3.5 MM 38 MM FULL THREAD | In distribution |
| 948170 | 3.5 MM 18 MM FULL THREAD | In distribution |
| 948851 | 4 MM 50 MM | In distribution |
| 348102 | 2.8 MM 15 MM | In distribution |
| 948492 | 2 MM 9 MM | In distribution |
| 948171 | 3.5 MM 18 MM FULL THREAD | In distribution |
| 348178 | 3.5 MM 26 MM FULL THREAD | In distribution |
| 348209 | 2.0 MM 60 MM | In distribution |
| 348207 | 2.0 MM 30 MM | In distribution |
| 948858 | 4 MM 58 MM | In distribution |
| 348461 | 5.0 MM 60 MM PARTITAL THREAD | In distribution |
| 948180 | 3.5 MM 28 MM FULL THREAD | In distribution |
| 348186 | 3.5 MM 34 MM FULL THREAD | In distribution |
| 348190 | 3.5 MM 38 MM FULL THREAD | In distribution |
| 948832 | 4 MM 32 MM FULL THREAD | In distribution |
| 348173 | 3.5 MM 20 MM FULL THREAD | In distribution |
| 948191 | 3.5 MM 38 MM FULL THREAD | In distribution |
| 948166 | 3.5 MM 14 MM FULL THREAD | In distribution |
| 348193 | 3.5 MM 40 MM FULL THREAD | In distribution |
| 348824 | 4 MM 24 MM | In distribution |
| 348100 | 2.8 MM 11 MM | In distribution |
| 948500 | 2.5 MM 5 MM | In distribution |
| 948496 | 2 MM 17 MM | In distribution |
| 948178 | 3.5 MM 26 MM FULL THREAD | In distribution |
| 948176 | 3.5 MM 24 MM FULL THREAD | In distribution |
| 348172 | 3.5 MM 20 MM FULL THREAD | In distribution |
| 348217 | 3.2 MM 40 MM | In distribution |
| 948824 | 4 MM 24 MM FULL THREAD | In distribution |
| 348834 | 4 MM 34 MM | In distribution |
| 348493 | 2.0 MM 11 MM | In distribution |
| 348107 | 2.8 MM 25 MM | In distribution |
| 948506 | 2.5 MM 17 MM | In distribution |
| 948495 | 2 MM 15 MM | In distribution |
| 348214 | 2.4 MM 55 MM | In distribution |
| 348822 | 4 MM 22 MM | In distribution |
| 948491 | 2 MM 7 MM | In distribution |
| 348850 | 4 MM 50 MM | In distribution |
| 948103 | 2.8 MM 17 MM | In distribution |
| 348192 | 3.5 MM 40 MM FULL THREAD | In distribution |
| 948182 | 3.5 MM 30 MM FULL THREAD | In distribution |
| 348446 | 5.0 MM 45 MM PARTITAL THREAD | In distribution |
| 348125 | 5 MM 25 MM FULL THREAD | In distribution |
| 948855 | 4 MM 54 MM | In distribution |
| 948830 | 4 MM 30 MM FULL THREAD | In distribution |
| 348180 | 3.5 MM 28 MM FULL THREAD | In distribution |
| 348504 | 2.5 MM 13 MM | In distribution |
| 348451 | 5.0 MM 50 MM PARTITAL THREAD | In distribution |
| 348440 | 5.0 MM 40 MM PARTITAL THREAD | In distribution |
| 348185 | 3.5 MM 32 MM FULL THREAD | In distribution |
| 948174 | 3.5 MM 22 MM FULL THREAD | 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 |
| 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2004-07-07 | Not classified | Other | Mislabeled as to size; 1.55 mm pins are labeled as 2mm. | 37 | 2004-10-07 |
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.