b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
B-One Ortho, Corp. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Cedar Knolls
- Advisory committee description
- Orthopedic
- Address 1
- 3 Wing Dr., Suite 259
- Statement or summary
- Summary
- Product code
- JWH
- Zip code
- 07927
- Applicant
- B-One Ortho, Corp.
- Decision date
- 2026-09-08
- Decision code
- SESE
- Country code
- US
- Device name
- b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions
- Advisory committee
- OR
- Contact
- Allison Gecik
- K number
- K262341
- State
- NJ
- Date received
- 2026-07-10
- Review advisory committee
- OR
- Postal code
- 07927
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3560
- Device class
- 2
- Registration number
- 2249615, 3012392319, 3014273644, 3013176080, 3006849754, 3013843055, 3026771806, 3010057495, 3010468876, 3010386387, 3012523063, 3010123256, 3008285983, 3009998573, 3003916006, 3003387384, 3004450489, 3019006180, 3015167917, 3016096064, 3008021110, 3015542154, 1724955, 1000200989, 3005596372, 3009882462, 2648920, 3005874553, 2531477, 3011187779, 2183744, 3006395932, 3002806603, 3008102042, 1423662, 3007963827, 3003541440, 3007334927, 3000236920, 3006694268 +280 more
- FEI number
- 3012392319, 3014273644, 3013176080, 3003714383, 3006849754, 3013843055, 1000116116, 3026771806, 3010057495, 3010386387, 3012523063, 3010123256, 3008285983, 3002459190, 3002807113, 3009998573, 3003916006, 3003387384, 3004450489, 3003110073, 1000115656, 3019006180, 3015167917, 3016096064, 3000215273, 3008021110, 3015542154, 3003142829, 1000200989, 3005596372, 3009882462, 3005874553, 3000205591, 3011187779, 2183744, 3006395932, 3002806603, 3007963827, 3002806534, 3003541440 +280 more