Print-ready dossier — use your browser's print dialog to save as PDF.
REVERE
Model 224.073 · GLOBUS MEDICAL, INC. · DI 00849044050127
KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050
KWQ — Appliance, Fixation, Spinal Intervertebral Body · Class II · 21 CFR 888.3060
MNH — Orthosis, Spondylolisthesis Spinal Fixation · Class II · 21 CFR 888.3070
MNI — Orthosis, Spinal Pedicle Fixation · Class II · 21 CFR 888.3070
NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.11
2019-02
0
1.94
2019-03
0
1.95
2019-04
0
1.98
2019-05
0
2.21
2019-06
0
2.45
2019-07
0
1.68
2019-08
0
2.8
2019-09
0
1.75
2019-10
0
1.91
2019-11
0
2.24
2019-12
0
1.65
2020-01
0
2.45
2020-02
0
2.21
2020-03
0
2.18
2020-04
0
1.61
2020-05
0
2.32
2020-06
0
1.91
2020-07
0
1.89
2020-08
0
1.93
2020-09
0
2.36
2020-10
0
2.56
2020-11
0
2.4
2020-12
0
2.04
2021-01
0
2.15
2021-02
0
1.86
2021-03
0
2.41
2021-04
0
2.2
2021-05
0
1.96
2021-06
0
1.97
2021-07
0
6.02
2021-08
0
2
2021-09
0
1.79
2021-10
0
2.56
2021-11
0
2.22
2021-12
0
2.35
2022-01
0
2.17
2022-02
0
2
2022-03
0
1.83
2022-04
0
1.94
2022-05
0
1.84
2022-06
0
2.04
2022-07
0
3.84
2022-08
0
1.96
2022-09
0
2.74
2022-10
0
1.49
2022-11
0
1.86
2022-12
0
2.09
2023-01
0
1.79
2023-02
0
1.87
2023-03
0
1.89
2023-04
0
1.94
2023-05
0
1.66
2023-06
0
1.71
2023-07
0
1.91
2023-08
0
1.56
2023-09
0
2.7
2023-10
0
2.62
2023-11
0
2.5
2023-12
0
1.7
2024-01
0
2.44
2024-02
0
2.18
2024-03
0
3.74
2024-04
0
1.73
2024-05
0
3.38
2024-06
0
2.45
2024-07
0
1.94
2024-08
0
1.95
2024-09
0
2.75
2024-10
0
2.12
2024-11
0
2.06
2024-12
0
1.81
2025-01
0
2.26
2025-02
0
2.5
2025-03
0
2.36
2025-04
0
2.33
2025-05
0
2.4
2025-06
0
2.18
2025-07
0
2.01
2025-08
0
1.95
2025-09
0
1.91
2025-10
0
1.95
2025-11
0
1.97
2025-12
0
2.41
2026-01
0
2.48
2026-02
0
2.44
2026-03
0
2.56
2026-04
0
1.9
2026-05
0
2.1
2026-06
0
4.45
This device (reports/month)Average device in KWP, KWQ, MNH, MNI, NKB (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K061202 — cited as predicate by K111449, K121670, K123783, K160775, K181068, K210420, K213820, K220285, K253739
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GLOBUS MEDICAL, INC.
Warning Letter 2024-07-15 Globus Medical, Inc.
Warning Letter 2024-07-15 Globus Medical, Inc.
Warning Letter 2013-09-26 Globus Medical, Inc.
Warning Letter 2013-09-26 Globus Medical, Inc.
VAI 2025-10-16 Globus Medical, Inc. · 1 citations
VAI 2025-10-16 Globus Medical, Inc. · 1 citations
OAI 2025-08-13 Nevro Corporation · 6 citations
NAI 2025-03-25 Nuvasive Manufacturing LLC. · 0 citations