VerteGlide Spinal Growth Guidance System
Verteglide 5.5 Polyaxial Pedicle Screw 6.0MM X 60MM, Closed
1manufacturer
204catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Fujian.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | PGM |
| Device type | Growing Rod System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K241816 |
| Record published | 2025-03-31 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1724-6060 | In distribution | |
| 00-1724-5035 | In distribution | |
| 00-1722-5530 | In distribution | |
| 00-1722-6555 | In distribution | |
| 00-1724-4540 | In distribution | |
| 00-1723-5545 | In distribution | |
| 00-1721-6020 | In distribution | |
| 00-1723-4530 | In distribution | |
| 00-1722-6060 | In distribution | |
| 00-1721-5035 | In distribution | |
| 00-1721-4525 | In distribution | |
| 00-1724-5045 | In distribution | |
| 00-1724-5040 | In distribution | |
| 00-1724-6525 | In distribution | |
| 00-1725-4515 | In distribution | |
| 00-1726-5560 | In distribution | |
| 00-1723-6045 | In distribution | |
| 00-1724-5055 | In distribution | |
| 00-1721-6045 | In distribution | |
| 00-1724-6025 | In distribution | |
| 00-1722-6525 | In distribution | |
| 00-1723-5030 | In distribution | |
| 00-1721-0045 | In distribution | |
| 00-1721-4550 | In distribution | |
| 00-1721-6560 | In distribution | |
| 00-1723-6550 | In distribution | |
| 00-1721-5540 | In distribution | |
| 00-1724-6560 | In distribution | |
| 00-1722-4525 | In distribution | |
| 00-1723-0010 | In distribution | |
| 00-1721-5520 | In distribution | |
| 00-1722-5560 | In distribution | |
| 00-1724-5050 | In distribution | |
| 00-1723-6540 | In distribution | |
| 00-1726-4515 | In distribution | |
| 00-1726-4512 | In distribution | |
| 00-1721-6055 | In distribution | |
| 00-1721-5525 | In distribution | |
| 00-1722-6045 | In distribution | |
| 00-1723-5560 | In distribution | |
| 00-1722-4560 | In distribution | |
| 00-1721-6060 | In distribution | |
| 00-1725-4560 | In distribution | |
| 00-1721-6530 | In distribution | |
| 00-1722-4555 | In distribution | |
| 00-1721-0010 | In distribution | |
| 00-1724-6030 | In distribution | |
| 00-1723-5535 | In distribution | |
| 00-1722-5050 | In distribution | |
| 00-1724-6055 | In distribution | |
| 00-1723-5550 | In distribution | |
| 00-1724-6050 | In distribution | |
| 00-1723-5525 | In distribution | |
| 00-1724-6045 | In distribution | |
| 00-1722-6530 | In distribution | |
| 00-1725-5515 | In distribution | |
| 00-1722-5545 | In distribution | |
| 00-1723-4560 | In distribution | |
| 00-1721-5060 | In distribution | |
| 00-1721-6030 | In distribution | |
| 00-1723-6060 | In distribution | |
| 00-1722-5520 | In distribution | |
| 00-1723-5040 | In distribution | |
| 00-1722-5525 | In distribution | |
| 00-1721-4545 | In distribution | |
| 00-1723-0055 | In distribution | |
| 00-1721-6025 | In distribution | |
| 01-1721-2500 | In distribution | |
| 00-1724-4530 | In distribution | |
| 00-1723-4520 | In distribution | |
| 00-1724-6555 | In distribution | |
| 00-1724-4560 | In distribution | |
| 00-1724-5025 | In distribution | |
| 00-1721-6540 | In distribution | |
| 00-1723-6530 | In distribution | |
| 00-1721-6050 | In distribution | |
| 00-1721-4530 | In distribution | |
| 00-1724-5555 | In distribution | |
| 00-1721-4535 | In distribution | |
| 00-1722-6055 | In distribution | |
| 00-1721-5550 | In distribution | |
| 00-1723-6555 | In distribution | |
| 00-1722-6540 | In distribution | |
| 00-1721-6040 | In distribution | |
| 00-1721-5025 | In distribution | |
| 00-1722-6030 | In distribution | |
| 00-1724-6020 | In distribution | |
| 00-1724-4545 | In distribution | |
| 00-1723-6560 | In distribution | |
| 00-1721-4555 | In distribution | |
| 00-1721-5050 | In distribution | |
| 00-1723-4550 | In distribution | |
| 00-1723-6020 | In distribution | |
| 00-1722-6535 | In distribution | |
| 00-1721-5030 | In distribution | |
| 00-1723-4540 | In distribution | |
| 00-1721-6545 | In distribution | |
| 00-1722-5025 | In distribution | |
| 00-1722-6050 | In distribution | |
| 00-1721-5560 | In distribution | |
| 00-1723-6035 | In distribution | |
| 00-1723-5025 | In distribution | |
| 00-1725-5590 | In distribution | |
| 00-1722-5035 | In distribution | |
| 00-1721-5530 | In distribution | |
| 00-1723-6520 | In distribution | |
| 00-1722-5550 | In distribution | |
| 00-1721-5535 | In distribution | |
| 00-1726-5512 | In distribution | |
| 00-1725-5560 | In distribution | |
| 00-1723-4535 | In distribution | |
| 00-1724-6545 | In distribution | |
| 00-1724-5530 | In distribution | |
| 00-1722-4535 | In distribution | |
| 00-1722-5045 | In distribution | |
| 00-1726-4590 | In distribution | |
| 00-1723-6050 | In distribution | |
| 00-1722-5020 | In distribution | |
| 00-1722-5055 | In distribution | |
| 00-1723-6040 | In distribution | |
| 00-1722-5030 | In distribution | |
| 00-1723-6525 | In distribution | |
| 00-1723-5035 | In distribution | |
| 00-1722-4540 | In distribution | |
| 00-1724-4520 | In distribution | |
| 00-1722-6020 | In distribution | |
| 00-1724-6540 | In distribution | |
| 00-1723-5555 | In distribution | |
| 00-1723-4555 | In distribution | |
| 00-1722-4530 | In distribution | |
| 00-1721-5055 | In distribution | |
| 00-1724-5030 | In distribution | |
| 00-1726-5515 | In distribution | |
| 00-1722-4520 | In distribution | |
| 00-1724-6035 | In distribution | |
| 01-1721-1500 | In distribution | |
| 00-1724-5540 | In distribution | |
| 00-1723-5050 | In distribution | |
| 00-1723-4545 | In distribution | |
| 00-1723-5055 | In distribution | |
| 01-1723-2500 | In distribution | |
| 00-1726-5590 | In distribution | |
| 00-1724-6040 | In distribution | |
| 00-1724-5550 | In distribution | |
| 00-1723-4525 | In distribution | |
| 00-1723-6025 | In distribution | |
| 00-1721-4560 | In distribution | |
| 00-1722-6560 | In distribution | |
| 00-1721-6550 | In distribution | |
| 01-1723-1500 | In distribution | |
| 00-1722-5535 | In distribution | |
| 00-1723-5540 | In distribution | |
| 00-1724-4525 | In distribution | |
| 00-1722-5040 | In distribution | |
| 00-1721-6520 | In distribution | |
| 00-1724-6530 | In distribution | |
| 00-1724-5520 | In distribution | |
| 00-1721-4540 | In distribution | |
| 00-1724-6535 | In distribution | |
| 00-1722-5555 | In distribution | |
| 00-1725-4512 | In distribution | |
| 00-1723-5520 | In distribution | |
| 00-1723-5060 | In distribution | |
| 00-1723-5530 | In distribution | |
| 00-1724-4535 | In distribution | |
| 00-1722-5060 | In distribution | |
| 00-1724-5060 | In distribution | |
| 00-1721-6555 | In distribution | |
| 00-1722-4545 | In distribution | |
| 00-1724-4550 | In distribution | |
| 00-1722-6025 | In distribution | |
| 00-1724-5560 | In distribution | |
| 00-1725-5512 | In distribution | |
| 00-1723-6030 | In distribution | |
| 00-1724-6550 | In distribution | |
| 00-1722-6520 | In distribution | |
| 00-1723-6055 | In distribution | |
| 00-1721-5020 | In distribution | |
| 00-1722-6035 | In distribution | |
| 00-1724-6520 | In distribution | |
| 00-1721-6035 | In distribution | |
| 00-1721-5045 | In distribution | |
| 00-1721-6525 | In distribution | |
| 00-1721-6535 | In distribution | |
| 00-1726-4560 | In distribution | |
| 00-1723-6545 | In distribution | |
| 00-1724-5545 | In distribution | |
| 00-1723-5020 | In distribution | |
| 00-1721-4520 | In distribution | |
| 00-1722-6545 | In distribution | |
| 00-1722-5540 | In distribution | |
| 00-1722-4550 | In distribution | |
| 00-1723-5045 | In distribution | |
| 00-1722-6550 | In distribution | |
| 00-1721-5555 | In distribution | |
| 00-1721-5545 | In distribution | |
| 00-1722-6040 | In distribution | |
| 00-1724-5525 | In distribution | |
| 00-1724-5535 | In distribution | |
| 00-1725-4590 | In distribution | |
| 00-1724-5020 | In distribution | |
| 00-1724-4555 | In distribution | |
| 00-1723-6535 | In distribution | |
| 00-1721-5040 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Growth Rod Conversion Set | Medtronic Sofamor Danek, Inc. | 37 |
| Shilla™ Growth Guidance System | Medtronic Sofamor Danek, Inc. | 23 |
| SDS Growing Rod | Baat Medical Products B.V. | 12 |
| Daytona® Small Stature | Seaspine Orthopedics Corporation | 8 |
| Expedium | Depuy Spine, Inc. | 6 |
| MSB Shilla Growth Guidance System | Medtronic Sofamor Danek, Inc. | 5 |
| XIA | Stryker GmbH | 4 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241816 | 2025-03-14 |
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.