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ALTA
Model NBT045025 · Astura Medical · DI 00840085278068
KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050
NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
OWI — Bone Fixation Cerclage, Sublaminar · Class II · 21 CFR 888.3010
PML — Bone Cement, Posterior Screw Augmentation · Class II · 21 CFR 888.3027
UDILibrary device dossier · generated 2026-09-12 · 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
2.35
2019-02
0
2.65
2019-03
0
2.42
2019-04
0
2.35
2019-05
0
2.61
2019-06
0
2.54
2019-07
0
2.16
2019-08
0
2.82
2019-09
0
2.24
2019-10
0
2.62
2019-11
0
3.4
2019-12
0
2.24
2020-01
0
2.76
2020-02
0
3.25
2020-03
0
3
2020-04
0
3.77
2020-05
0
2.38
2020-06
0
2.28
2020-07
0
2.52
2020-08
0
2.21
2020-09
0
2.77
2020-10
0
3.91
2020-11
0
3.25
2020-12
0
2.74
2021-01
0
3.15
2021-02
0
2.66
2021-03
0
2.88
2021-04
0
2.75
2021-05
0
2.88
2021-06
0
2.75
2021-07
0
4.65
2021-08
0
2.23
2021-09
0
2.17
2021-10
0
2.34
2021-11
0
2.59
2021-12
0
2.4
2022-01
0
2.27
2022-02
0
2.4
2022-03
0
2.31
2022-04
0
2.15
2022-05
0
2.72
2022-06
0
2.89
2022-07
0
3.8
2022-08
0
2.22
2022-09
0
2.56
2022-10
0
2.25
2022-11
0
2.34
2022-12
0
2.85
2023-01
0
2.34
2023-02
0
2.47
2023-03
0
2.48
2023-04
0
2.35
2023-05
0
2.08
2023-06
0
2.01
2023-07
0
2.23
2023-08
0
2.07
2023-09
0
3.19
2023-10
0
2.84
2023-11
0
4.96
2023-12
0
2.8
2024-01
0
2.64
2024-02
0
2.99
2024-03
0
3.75
2024-04
0
2.47
2024-05
0
3.96
2024-06
0
3.21
2024-07
0
2.66
2024-08
0
2.84
2024-09
0
3.62
2024-10
0
3.87
2024-11
0
3.19
2024-12
0
2.76
2025-01
0
5.1
2025-02
0
3.3
2025-03
0
2.78
2025-04
0
3.1
2025-05
0
3.32
2025-06
0
3.15
2025-07
0
2.9
2025-08
0
3.42
2025-09
0
2.71
2025-10
0
2.98
2025-11
0
2.91
2025-12
0
3.45
2026-01
0
3.29
2026-02
0
3.11
2026-03
0
3.06
2026-04
0
2.78
2026-05
0
3.53
2026-06
0
4.01
This device (reports/month)Average device in KWP, NKB, OLO, OWI, PML (reports/device/month)