Arcus
Arcus Guided Access System - Diamond Tip, Sterile
1manufacturer
4catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | PDQ |
| Device type | Neurosurgical Nerve Locator |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K191723 |
| Record published | 2021-02-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16122-01-S | In distribution | |
| 16122-02 | In distribution | |
| 16122-02-S | In distribution | |
| 16122-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pulse | Nuvasive, Inc. | 21 |
| Pediguard Threaded | Spineguard, SA | 19 |
| NVM5 | Nuvasive, Inc. | 15 |
| Alara Neuro Access Needle Kit | Surgentec LLC | 12 |
| SafeOp | Alphatec Spine, Inc. | 9 |
| Sentio | Medos International Sàrl | 8 |
| TSI | Tedan Surgical Innovations, L.L.C. | 8 |
| SentioMMG | Innovative Surgical Solutions LLC | 7 |
| PediGuard DSG Connect | Spineguard, SA | 6 |
| Fresh Whole Blood Donor Transfusion Set | Safeguard US Operating, LLC | 5 |
| Bendini | Nuvasive, Inc. | 4 |
| Boston Endo Surgical Technologies LLC | Lacey Manufacturing Company LLC | 4 |
Showing 12 of 63. All products under Neurosurgical Nerve Locator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221821 | 2022-09-23 |
| K191723 | 2019-10-18 |
| K182617 | 2019-05-09 |
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.