PALACOS MV pro— 510(k) K213812
Substantially EquivalentHeraeus Medical GmbH
FDA 510(k) clearance K213812 for PALACOS MV pro, Substantially Equivalent on 2022-02-02. Applicant: Heraeus Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Heraeus Medical GmbH
- Product code
- Product code LOD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wehrheim, DE
Recent devices under product code LOD
view allMore clearances from Heraeus Medical GmbH
view allAdverse events under product code LOD
product code LOD- Death
- 44
- Injury
- 3,004
- Malfunction
- 895
- Other
- 4
- Total
- 3,947
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 K213812
K-number listed on FDA's recall record- Z-3304-2026 — PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
- Z-1083-2026 — Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213812.
Data sourced from openFDA. This site is unofficial and independent of the FDA.