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CastleLoc Pectus Bar System Instrument Set
Model PB01-0020-04 · L&K BIOMED CO. ,LTD. · DI 08809986460363
LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-06 · 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
2.43
2019-02
0
2.31
2019-03
0
2.25
2019-04
0
2.08
2019-05
0
2.21
2019-06
0
2.28
2019-07
0
2.37
2019-08
0
2.23
2019-09
0
2.68
2019-10
0
2.1
2019-11
0
2.09
2019-12
0
2.29
2020-01
0
2.34
2020-02
0
2.07
2020-03
0
2.14
2020-04
0
2.25
2020-05
0
2.09
2020-06
0
2.65
2020-07
0
3.62
2020-08
0
3.36
2020-09
0
3.49
2020-10
0
4.02
2020-11
0
3.63
2020-12
0
3.57
2021-01
0
3.73
2021-02
0
3.67
2021-03
0
3.23
2021-04
0
3.49
2021-05
0
3.18
2021-06
0
3.03
2021-07
0
2.66
2021-08
0
3.22
2021-09
0
2.79
2021-10
0
2.52
2021-11
0
3.11
2021-12
0
2.67
2022-01
0
2.6
2022-02
0
3.13
2022-03
0
3.17
2022-04
0
3.52
2022-05
0
3.71
2022-06
0
2.82
2022-07
0
2.5
2022-08
0
2.59
2022-09
0
2.82
2022-10
0
3.08
2022-11
0
3.6
2022-12
0
3.74
2023-01
0
4.57
2023-02
0
3.11
2023-03
0
3.63
2023-04
0
3.08
2023-05
0
3.19
2023-06
0
3.19
2023-07
0
2.85
2023-08
0
2.89
2023-09
0
2.22
2023-10
0
2.4
2023-11
0
3.21
2023-12
0
3.04
2024-01
0
2.84
2024-02
0
3.03
2024-03
0
2.79
2024-04
0
3.59
2024-05
0
3.57
2024-06
0
3.68
2024-07
0
2.83
2024-08
0
2.74
2024-09
0
3.06
2024-10
0
3.11
2024-11
0
2.81
2024-12
0
2.56
2025-01
0
2.86
2025-02
0
4.24
2025-03
0
5.06
2025-04
0
2.79
2025-05
0
2.85
2025-06
0
2.78
2025-07
0
2.56
2025-08
0
2.6
2025-09
0
2.15
2025-10
0
2.32
2025-11
0
2.66
2025-12
0
3.79
2026-01
0
3.54
2026-02
0
3.48
2026-03
0
3.22
2026-04
0
3.13
2026-05
0
2.6
2026-06
0
3.35
This device (reports/month)Average device in LXH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — L&K BIOMED CO. ,LTD.