SureMAX-SA
Inner Shaft FOR Inserter AND AWL Guides
1manufacturer
34catalogue 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) | K211111 |
| Record published | 2021-09-30 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 4.3 to 25 mm; length 14.75 to 152.4 mm; length 136 µm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 136 µm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 152.4 mm | In distribution |
| 1 | In distribution | |
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| 1 | In distribution | |
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| 1 | In distribution | |
| 1 | Length 14.75 mm | In distribution |
| 1 | In distribution | |
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| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integrate-C | Happe Spine | 124 |
| SureMAX | Additive Implants | 16 |
| 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.