PTS
Sterile 14mm Distraction Screw - Box of 10, Gryphon
1manufacturer
12catalogue 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 | PT Solutions, LLC, United States |
|---|---|
| FDA product code | LYQ |
| Device type | Accessories, Fixation, Spinal Intervertebral Body |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 12 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S10-909-16DS | In distribution | |
| S10-909-14DS | In distribution | |
| S1-909-14DS | Outer Diameter 14 mm | In distribution |
| G1-909-14DS | Outer Diameter 14 mm | In distribution |
| G1-909-12DS | Outer Diameter 12 mm | In distribution |
| S1-909-16DS | Outer Diameter 16 mm | In distribution |
| G10-909-14DS | In distribution | |
| G10-909-16DS | In distribution | |
| G10-909-12DS | In distribution | |
| G1-909-16DS | Outer Diameter 16 mm | In distribution |
| S1-909-12DS | Outer Diameter 12 mm | In distribution |
| S10-909-12DS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integrate-C | Happe Spine | 124 |
| SureMAX-SA | Additive Implants | 34 |
| SureMAX | Additive Implants | 16 |
| 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.