Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
Predicate lineage
- K250599
- K161379
- K172341
- K191100
- K193541
- K200953
- K201692
- K203278
- K203714
- K211616
- K222270
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-10-16 | VAI | Voluntary action indicated | Globus Medical, Inc. | 1 |
| 2025-10-16 | VAI | Voluntary action indicated | Globus Medical, Inc. | 1 |
| 2025-08-13 | OAI | Official action indicated | Nevro Corporation | 6 |
| 2025-03-25 | NAI | No action indicated | Nuvasive Manufacturing LLC. | 0 |
| 2024-07-15 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2024-07-15 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2024-03-07 | OAI | Official action indicated | Globus Medical, Inc. | 6 |
| 2024-03-07 | OAI | Official action indicated | Globus Medical, Inc. | 6 |
| 2023-12-20 | VAI | Voluntary action indicated | Nevro Corporation | 1 |
| 2022-07-29 | NAI | No action indicated | Nevro Medical SRL | 0 |
| 2022-04-26 | NAI | No action indicated | Nevro Corporation | 0 |
| 2019-10-23 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2019-10-23 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2019-09-27 | VAI | Voluntary action indicated | Globus Medical, Inc. | 7 |
| 2019-09-27 | VAI | Voluntary action indicated | Globus Medical, Inc. | 7 |
| 2019-03-21 | NAI | No action indicated | Nevro Corporation | 0 |
| 2019-02-13 | VAI | Voluntary action indicated | Globus Medical, Inc. | 2 |
| 2019-02-13 | VAI | Voluntary action indicated | Globus Medical, Inc. | 2 |
| 2018-03-16 | NAI | No action indicated | Nevro Corporation | 0 |
| 2017-11-03 | VAI | Voluntary action indicated | Nevro Corporation | 5 |
| 2017-09-25 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2017-09-25 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2013-09-26 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2013-09-26 | WL | Warning Letter | Globus Medical, Inc. | — |
Similar devices
- ENDSCP NAV INTERFACE (Ø 6,1 mm) MEDTECH
- ENDSCP NAV INTERFACE (Ø 6,7 mm) MEDTECH
- Paradigm Navigated Drill Guide Case Tray Proprio, Inc.
- "7D Surgical Ratcheting Handle, 1/4"" Square" 7D Surgical ULC
- "CI FEM&TIB CUT BLOCK ADP "" DEPUY PFC SP2""" Brainlab SE
- "icotec Systems, Handle, 1/4"" Coupling" icotec AG
- 10.5 Arm Guide KIT MAZOR ROBOTICS LTD
- 10.5 Arm Guide KIT MAZOR ROBOTICS LTD
- 10.5 Arm Guide Screw Kit MAZOR ROBOTICS LTD
- 10.5 Arm Guide Screw Kit MAZOR ROBOTICS LTD
- 11-0052 7D Flex Rod Connector - ø5.5mm - 150mm 7D Surgical ULC
- 2-Pin Drill Template, X-Press Brainlab SE
Select up to two to place side-by-side with this device.