VerteLoc Spinal System
by Signature Orthopaedics Pty Ltd
510(k) K231134
VerteLoc Spinal System is a Class II device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K231134 on 13 Feb 2024 and listed in FDA GUDID since 4 Mar 2024 (UDI-DI 09348215129071), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number09348215129071 | Date4 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK231134 | Date13 Feb 2024 | StatusActive |
Official records
- AccessGUDID record 09348215129071
- FDA 510(k) database K231134
Across registries
- FDA 510(k) K231134 decided 13 Feb 2024 Active
- FDA GUDID UDI-DI 09348215129071 listed 4 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K231134
- Listed FDA GUDID 09348215129071
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Polymeric spinal interbody fusion cage
- Model / reference
- 131-14-1711
- FDA applicant
- Signature Orthopaedics Pty, Ltd.
- Primary DI / UDI-DI
- 09348215129071
- 510(k) Number
- FDA product code
- MQP 510(k)PLR GUDID
- GMDN term
- Polymeric spinal interbody fusion cage
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | 510(k) | GUDID |
|---|---|---|
| FDA product code | MQP | PLR |
Devices cleared under K231134
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Verteloc Spinal System 131-14-0008 | 131-14-0008 | 09348215129095 | — | On the market |
| Verteloc Spinal System 131-14-0010 | 131-14-0010 | 09348215129101 | — | On the market |
| Verteloc Spinal System 131-14-0020 | 131-14-0020 | 09348215129118 | — | On the market |
| Verteloc Spinal System 131-14-0030 | 131-14-0030 | 09348215129125 | — | On the market |
| Verteloc Spinal System 131-14-0040 | 131-14-0040 | 09348215129132 | — | On the market |
| Verteloc Spinal System 131-14-1005 | 131-14-1005 | 09348215128975 | — | On the market |
| Verteloc Spinal System 131-14-1009 | 131-14-1009 | 09348215128982 | — | On the market |
| Verteloc Spinal System 131-14-1011 | 131-14-1011 | 09348215128999 | — | On the market |
| Verteloc Spinal System 131-14-1013 | 131-14-1013 | 09348215129002 | — | On the market |
| Verteloc Spinal System 131-14-1505 | 131-14-1505 | 09348215129019 | — | On the market |
| Verteloc Spinal System 131-14-1509 | 131-14-1509 | 09348215129026 | — | On the market |
| Verteloc Spinal System 131-14-1511 | 131-14-1511 | 09348215129033 | — | On the market |
| Verteloc Spinal System 131-14-1513 | 131-14-1513 | 09348215129040 | — | On the market |
| Verteloc Spinal System 131-14-1705 | 131-14-1705 | 09348215129057 | — | On the market |
| Verteloc Spinal System 131-14-1709 | 131-14-1709 | 09348215129064 | — | On the market |
| Verteloc Spinal System 131-14-1711 | 131-14-1711 | 09348215129071 | — | On the market |
| Verteloc Spinal System 131-14-1713 | 131-14-1713 | 09348215129088 | — | On the market |
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