BonVie+
Elute, Inc. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Salt Lake City
- Advisory committee description
- Orthopedic
- Address 1
- 417 Wakara Way, Suite 3510
- Statement or summary
- Summary
- Product code
- MQV
- Zip code
- 84108
- Applicant
- Elute, Inc.
- Decision date
- 2025-02-26
- Decision code
- SESE
- Country code
- US
- Device name
- BonVie+
- Advisory committee
- OR
- Contact
- Ashok Khandkar
- K number
- K250346
- State
- UT
- Date received
- 2025-02-06
- Review advisory committee
- OR
- Postal code
- 84108
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Filler, Bone Void, Calcium Compound
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3045
- Device class
- 2
- Registration number
- 3019403037, 3011964577, 9610612, 3011662387, 3005064037, 3018094310, 1720734, 3008868758, 3010376334, 8043792, 3005972619, 3006788678, 1226544, 3008514120, 3005381997, 3003828812, 3005180920, 1645368, 2530154, 3015219237, 3002636527, 3030412764, 3027448274, 3013497559, 3008114965, 3003477135, 3008328709, 3004111573, 2030598, 3013820501, 2953359, 3033509898, 3008812560, 3006017180, 3012329552, 3011415547, 3011121816, 3006404071, 3002807310, 2246552 +186 more
- FEI number
- 3019403037, 3011964577, 3011662387, 3005064037, 3018094310, 1720734, 1000477302, 3008868758, 3005972619, 3006788678, 3000303710, 3008514120, 3005381997, 3003828812, 3005180920, 3002808269, 3006813973, 3002807172, 3015219237, 3003414678, 3002807091, 3003015552, 3030412764, 3027448274, 3002636527, 3013497559, 3008114965, 3003477135, 3008328709, 3004111573, 3013820501, 3033509898, 3002924544, 3008812560, 3006017180, 3012329552, 3011415547, 3011121816, 3006404071, 3002807310 +186 more