SureMAX
Cervical Inserter without Guard Assembly
1manufacturer
16catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Additive Implants, United States |
|---|---|
| FDA product code | LYQ |
| Device type | Accessories, Fixation, Spinal Intervertebral Body |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K182477 |
| Record published | 2019-02-21 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Outer diameter 6 to 31.5 mm; length 4 to 263 mm; lumen/inner diameter 3 to 8.8 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Lumen/Inner Diameter 8.8 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.4 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Length 211.3 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.4 mm | In distribution |
| 1 | Lumen/Inner Diameter 3 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.4 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.4 mm | In distribution |
| 1 | Lumen/Inner Diameter 3 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.4 mm | In distribution |
| 1 | Length 263 mm | In distribution |
| 1 | Length 203.3 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.3 mm | In distribution |
| 1 | Lumen/Inner Diameter 3.3 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integrate-C | Happe Spine | 124 |
| SureMAX-SA | Additive Implants | 34 |
| PTS | PT Solutions, LLC | 12 |
| Riva Posterior Fixation System | Xenix Medical | 8 |
| KeyLift™ | Flospine LLC | 6 |
| Riva Pedicle Screw System | Xenix Medical | 6 |
| Coda™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 3 |
| Distraction Screw, 12MM Pouch | Medline Industries, Inc. | 2 |
| Distraction Screw, 14MM pouch | Medline Industries, Inc. | 2 |
| LUX Expandable Interbody System | Xenix Medical | 2 |
| Distraction Pin, 12MM Pouch | Medline Industries, Inc. | 2 |
| ABS Med Distraction Pin | Medline Industries, Inc. | 2 |
Showing 12 of 22. All products under Accessories, Fixation, Spinal Intervertebral Body
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.