PALAMED
FDA 510(k) clearance K030904 · decided 2003-09-23
Clearance details
- K-number
- K030904
- Device name
- PALAMED
- Applicant
- Heraeus Medical GmbH Technology
- Decision
- Substantially Equivalent
- Date received
- 2003-03-24
- Decision date
- 2003-09-23
- Days to decision
- 183 days
- Clearance type
- Abbreviated
- 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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| BonOs HV, BonOs MV, BonOs LV (K210120) | Osartis GmbH | 2021-03-19 |
Recalls involving this device
No recalls on record reference this clearance.