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CRANIOS Reinforced
Model 615.05.01S · Synthes GmbH · DI 10887587058641
GXP — Methyl Methacrylate For Cranioplasty · Class II · 21 CFR 882.5300
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 (17)
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.
Injury: 17
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
2019-03
0
1
2019-05
0
1
2019-06
0
1
2019-11
0
1
2019-12
0
1
2020-01
0
2
2020-02
0
1
2020-05
0
1
2020-08
9
4.25
2020-11
5
3
2021-02
2
1.5
2021-03
0
2
2021-04
0
1
2021-05
0
2
2021-07
0
3
2021-11
0
2
2022-03
0
1
2022-06
1
1
2023-07
0
1
2024-04
0
1
2024-07
0
1
2024-10
0
1.6
2025-10
0
1
2026-02
0
2
2026-06
0
1
This device (reports/month)Average device in GXP (reports/device/month)
Regulatory clearances
K102018 SESE 2010-09-23 (k number procode)
Predicate lineage
K102018 — cites (transitively): K012589 (d1)
Lineage extracted from public 510(k) summary text (heuristic).