iFuse Bedrock Granite® Implant System
SI-BONE, Inc. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Santa Clara
- Advisory committee description
- Orthopedic
- Address 1
- 471 El Camino Real
- Address 2
- Suite 101
- Statement or summary
- Summary
- Product code
- OUR
- Zip code
- 95050
- Applicant
- SI-BONE, Inc.
- Decision date
- 2024-01-26
- Decision code
- SESE
- Country code
- US
- Device name
- iFuse Bedrock Granite® Implant System
- Advisory committee
- OR
- Contact
- Jayasri Prabakaran
- K number
- K233508
- State
- CA
- Date received
- 2023-10-31
- Review advisory committee
- OR
- Postal code
- 95050
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Sacroiliac Joint Fixation
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3040
- Device class
- 2
- Registration number
- 3018094310, 3008868758, 1057425, 8043792, 3010593798, 3009790163, 3011656326, 3008514120, 3010047402, 3025141, 3005180920, 3005706667, 3007125392, 3007700286, 2134285, 3009051471, 3005977257, 3019837678, 3006846753, 3030412764, 3010143171, 3003477135, 3013564228, 3005641619, 1222773, 3033509898, 3008812560, 3006017180, 3024124172, 3005819474, 3003761012, 3010667733, 3012103114, 3013912820, 3000203391, 3043543260, 3010326971, 3014919610, 3004188066, 3008285983 +123 more
- FEI number
- 1000477302, 3018094310, 3008868758, 3010593798, 3009790163, 3011656326, 3008514120, 3003058119, 3010047402, 3005180920, 3005706667, 3007125392, 3002808269, 3007700286, 3009051471, 3005977257, 3019837678, 3011764740, 3006846753, 3003015552, 3030412764, 3010143171, 3003477135, 3013564228, 3005641619, 3033509898, 3008812560, 3006017180, 1000136451, 3024124172, 3005819474, 3003761012, 3010667733, 3012103114, 3013912820, 3000203391, 3043543260, 3010326971, 3002287318, 3014919610 +123 more