Bone Screws 6.5mm— 510(k) K172456
Substantially EquivalentLima Corporate S.P.A.
FDA 510(k) clearance K172456 for Bone Screws 6.5mm, Substantially Equivalent on 2018-01-04. Applicant: Lima Corporate S.P.A.. Device class: 2.
Clearance details
- Applicant
- Lima Corporate S.P.A.
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Udine, IT
Recent devices under product code LPH
view allMore clearances from Lima Corporate S.P.A.
view allAdverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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 K172456
K-number listed on FDA's recall record- Z-0159-2022 — REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
- Z-0160-2022 — REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172456.
Data sourced from openFDA. This site is unofficial and independent of the FDA.