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Anterior Cervical Interbody Fusion Device
Model HTR-45-0011 · PRECISION SPINE, INC. · DI 00840019921794
HTR — Rasp · Class I · 21 CFR 878.4800
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
2019-03
0
3
2019-06
0
2
2019-07
0
1
2019-10
0
3
2020-03
0
3
2020-06
0
1
2021-01
0
1
2021-04
0
1
2021-09
0
1
2021-12
0
2
2022-01
0
1
2022-03
0
1.5
2022-04
0
2
2022-05
0
1
2022-06
0
4
2022-10
0
2
2022-12
0
1
2023-01
0
2
2023-04
0
1
2023-09
0
1
2023-11
0
1
2023-12
0
1
2024-01
0
2
2024-03
0
1
2024-06
0
1
2024-07
0
3
2024-10
0
1
2025-01
0
1
2025-07
0
4
2025-08
0
1
2026-02
0
1
2026-03
0
2
2026-05
0
3
2026-06
0
2
This device (reports/month)Average device in HTR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — PRECISION SPINE, INC.