RECON system-V-TEK-IVP Plates and Screws— 510(k) K152312
Substantially EquivalentNormed Medizin-Technik GmbH
FDA 510(k) clearance K152312 for RECON system-V-TEK-IVP Plates and Screws, Substantially Equivalent on 2015-10-30. Applicant: Normed Medizin-Technik GmbH. Device class: 2.
Clearance details
- Applicant
- Normed Medizin-Technik GmbH
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
Recent devices under product code HRS
view allMore clearances from Normed Medizin-Technik GmbH
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K152312
K-number listed on FDA's recall record- Z-1445-2019 — V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634
- Z-1447-2019 — V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636
- Z-1448-2019 — V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
- Z-1449-2019 — V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152312.
Data sourced from openFDA. This site is unofficial and independent of the FDA.