Stratum Foot Plating System— 510(k) K182201
Substantially EquivalentNextremity Solutions, Inc.
FDA 510(k) clearance K182201 for Stratum Foot Plating System, Substantially Equivalent on 2018-11-16. Applicant: Nextremity Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Nextremity Solutions, Inc.
- 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
- Warsaw, IN, US
Recent devices under product code HRS
view allMore clearances from Nextremity Solutions, Inc.
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 K182201
K-number listed on FDA's recall record- Z-1127-2020 — Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
- Z-0776-2020 — Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
- Z-0777-2020 — Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
- Z-0778-2020 — Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
- Z-0534-2020 — Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182201.
Data sourced from openFDA. This site is unofficial and independent of the FDA.