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OMNISPAN ORTHOCORD
Model 228141 · Medos International Sàrl · DI 10886705010035
GAT — Suture, Nonabsorbable, Synthetic, Polyethylene · Class II · 21 CFR 878.5000
HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040
JDR — Staple, Fixation, Bone · Class II · 21 CFR 888.3030
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
NEW — Suture, Surgical, Absorbable, Polydioxanone · Class II · 21 CFR 878.4840
UDILibrary device dossier · generated 2026-09-13 · 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 (462)
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.
Malfunction: 448 · Injury: 14
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
24
4.57
2019-02
3
2.6
2019-03
0
3.45
2019-04
1
3.33
2019-05
3
3.15
2019-06
1
3.11
2019-07
6
3.62
2019-08
3
3.74
2019-09
8
3.92
2019-10
5
3.72
2019-11
6
4.59
2019-12
5
4.75
2020-01
5
4.79
2020-02
1
3.72
2020-03
2
4.43
2020-04
6
5.91
2020-05
1
4.24
2020-06
9
4.29
2020-07
4
4.32
2020-08
0
4.54
2020-09
0
3.97
2020-10
1
4.51
2020-11
23
5.97
2020-12
2
5.53
2021-01
6
5.32
2021-02
6
4.7
2021-03
1
4.81
2021-04
2
5.04
2021-05
2
4.72
2021-06
2
4.26
2021-07
2
4.85
2021-08
1
4.52
2021-09
3
4.68
2021-10
3
4.98
2021-11
2
5.09
2021-12
1
5.04
2022-01
6
4.67
2022-02
2
4.37
2022-03
1
4.86
2022-04
0
4.45
2022-05
1
4.93
2022-06
2
4.22
2022-07
1
4.36
2022-08
19
5.82
2022-09
3
4.68
2022-10
14
5.29
2022-11
2
4.83
2022-12
6
5.4
2023-01
3
5.58
2023-02
1
5.46
2023-03
3
6.1
2023-04
2
6.58
2023-05
2
6.67
2023-06
8
7.12
2023-07
4
6.4
2023-08
9
6.63
2023-09
2
5.65
2023-10
5
6.61
2023-11
5
4.84
2023-12
15
6.41
2024-01
7
5.68
2024-02
7
6.45
2024-03
4
8.97
2024-04
5
13.7
2024-05
16
13.88
2024-06
7
14.96
2024-07
6
13.82
2024-08
4
8.5
2024-09
1
8.31
2024-10
3
6.11
2024-11
11
6.2
2024-12
6
5.48
2025-01
8
5.69
2025-02
1
4.69
2025-03
5
5.06
2025-04
6
5.32
2025-05
3
5.79
2025-06
8
5.63
2025-07
11
5
2025-08
12
5.41
2025-09
1
4.37
2025-10
4
4.79
2025-11
6
6.43
2025-12
6
5.95
2026-01
14
5.86
2026-02
6
6.39
2026-03
4
5.9
2026-04
3
6.05
2026-05
13
6.75
2026-06
8
6.75
This device (reports/month)Average device in GAT, HTY, JDR, MAI, MBI, NEW (reports/device/month)
Regulatory clearances
K092836 SESE 2010-02-04 (k number procode)
Predicate lineage
K092836 — cites (transitively): K002406 (d1), K023388 (d1), K072322 (d1) — cited as predicate by K153667
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl