Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Materialise NV · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Leuven
- Advisory committee description
- Orthopedic
- Address 1
- Technologielaan 15
- Statement or summary
- Summary
- Product code
- QHE
- Zip code
- 3001
- Applicant
- Materialise NV
- Decision date
- 2024-05-22
- Decision code
- SESE
- Country code
- BE
- Device name
- Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- Advisory committee
- OR
- Contact
- Lisa Barbara Parolari
- K number
- K241143
- Date received
- 2024-04-25
- Review advisory committee
- OR
- Postal code
- 3001
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Shoulder Arthroplasty Implantation System
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3660
- Device class
- 2
- Registration number
- 3009555447, 3007841013, 3006990600, 1822565, 1649390, 9617840, 3002579136, 3011724582, 3003018722, 3014833750, 2249608, 3014027736, 3000931034, 3009555440, 3010236732, 3005180920, 3008110533, 1043534, 1220246, 3016851379, 3008388276, 3013552417, 3013561205, 3005718816, 3014262693, 3015806723, 3010331645, 3015231789, 1064858, 3003998208, 3031914485, 3004983210, 3020704423, 3012470322, 3006721341, 3014004349
- FEI number
- 3009555447, 3007841013, 3006990600, 3002579136, 3011724582, 3003018722, 3014833750, 3000931034, 3014027736, 3009555440, 3010236732, 3005180920, 3008110533, 1043534, 1220246, 3016851379, 3008388276, 3013552417, 3013561205, 3005718816, 3014262693, 3015806723, 3010331645, 3015231789, 3008397795, 3003998208, 3031914485, 1000220733, 3004983210, 3020704423, 3012470322, 3006721341, 3000718467, 3014004349, 3003714383, 3002943267