PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
FDA 510(k) clearance K210607 · decided 2021-07-09
Clearance details
- K-number
- K210607
- Device name
- PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
- Applicant
- Heraeus Medical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-03-01
- Decision date
- 2021-07-09
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- LOD
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Wehrheim, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: recall (Z-1080-2026) | Heraeus Medical GmbH (Dental Division) | 2026-01-14 |
| Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Num recall (Z-1081-2026) | Heraeus Medical GmbH (Dental Division) | 2026-01-14 |
| Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog N recall (Z-1082-2026) | Heraeus Medical GmbH (Dental Division) | 2026-01-14 |