FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PALACOS MV
K Number: K182260
·
Decision Sep 17, 2018
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
13
Review Days
27
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Basic Information
- Device Name
- PALACOS MV
- K Number
- K182260
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Medical GmbH
- Date Received
- August 21, 2018
- Decision Date
- September 17, 2018
- Product Code
- LOD
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |
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Other Clearances by Heraeus Medical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K241674 | OSTEOPAL® V | Dec 5, 2024 | Substantially Equivalent |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | Feb 15, 2024 | Substantially Equivalent |
| K222570 | COPAL knee moulds | Feb 4, 2023 | Substantially Equivalent |
| K220492 | COPAL exchange G hip spacer | Mar 23, 2022 | Substantially Equivalent |
| K213812 | PALACOS MV pro | Feb 2, 2022 | Substantially Equivalent |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Jul 9, 2021 | Substantially Equivalent |
| K202475 | PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G | Nov 23, 2020 | Substantially Equivalent |
| K191016 | COPAL exchange G Hip and Knee Spacers | Nov 1, 2019 | Substantially Equivalent |
| K190766 | PALACOS fast R+G | May 31, 2019 | Substantially Equivalent |
| K153737 | OSTEOPAL plus | Apr 22, 2016 | Substantially Equivalent |