PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro— 510(k) K210607
Substantially EquivalentHeraeus Medical GmbH
FDA 510(k) clearance K210607 for PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro, Substantially Equivalent on 2021-07-09. Applicant: Heraeus Medical GmbH. Device class: 2.
Clearance details
- Applicant
- Heraeus Medical GmbH
- Product code
- 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 K210607
K-number listed on FDA's recall record- Z-1080-2026 — Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 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
- Z-1081-2026 — Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 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
- Z-1082-2026 — Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 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 K210607.
Data sourced from openFDA. This site is unofficial and independent of the FDA.