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Align
Model ALIGN, Neck Gauge & Head Inserter, 0mm · SKELETAL DYNAMICS L.L.C. · DI 00841506100708
KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer · Class II · 21 CFR 888.3170
UDILibrary device dossier · generated 2026-09-07 · 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
1.5
2019-02
0
1
2019-03
0
1.09
2019-04
0
1
2019-05
0
1
2019-06
0
1
2019-07
0
1
2019-08
0
1
2019-09
0
1
2019-10
0
1
2019-11
0
1
2019-12
0
1
2020-01
0
1
2020-02
0
1
2020-03
0
1
2020-04
0
2
2020-05
0
1
2020-07
0
1
2020-08
0
1
2020-09
0
1
2020-10
0
1
2020-11
0
1
2020-12
0
1
2021-01
0
1
2021-03
0
1
2021-04
0
1
2021-07
0
2
2021-08
0
1.5
2021-09
0
1
2021-10
0
1
2021-11
0
1
2022-01
0
1
2022-04
0
1.4
2022-05
0
1
2022-06
0
1.5
2022-09
0
1
2022-10
0
1.5
2022-11
0
1.4
2022-12
0
1.67
2023-01
0
1
2023-02
0
1
2023-03
0
1
2023-04
0
1
2023-05
0
1
2023-07
0
2.33
2023-08
0
1.33
2023-09
0
1
2023-10
0
1
2023-11
0
1
2023-12
0
1
2024-01
0
1
2024-02
0
2
2024-03
0
1
2024-04
0
1
2024-05
0
1
2024-06
0
1
2024-07
0
1.67
2024-08
0
1.25
2024-09
0
2.23
2024-10
0
2
2024-11
0
1
2025-03
0
1.62
2025-04
0
1
2025-07
0
1
2025-08
0
1.5
2025-09
0
1
2025-11
0
1
2025-12
0
1
2026-03
0
1.5
2026-04
0
1
2026-05
0
2
This device (reports/month)Average device in KWI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K092721 — cites (transitively): K041858 (d1), K051383 (d1), K051385 (d1) — cited as predicate by K231188
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SKELETAL DYNAMICS L.L.C.