510(k) K260796
- Device
- Tahoe Unicondylar Knee System with TiNbN Overcoat
- Applicant
- Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
- 510(k) number
- K260796
- Product code
- HSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-02
- Date received
- 2026-03-11
- Regulation
- 888.3520
- Classification name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Romil Sheth
- Address
- 1115 Windfield Way El Dorado Hills CA US 95762 95762
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 2242737
- 3005180920
- 2133928
- 3009241418
- 3013176080
- 3017410889
- 3021008900
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- 3002579136
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- 3004142400
- 1643264
- 1223434
- 3016090213
- 2028632
- 3004358587
- 1043653
- 1219655
- 2246552
- 3014763043
- 1721676
- 3011061242
- 2532027
- 3010041693
- 3006395932
- 3004976965
- 3013302242
- 3013014058
- 3010039400
- 2249697
- 3010331645
- 3012523063
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- 3002907620
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- 3002808022
- 3004153240
- 3038503932
- 9681465
- 3010400367
- 3011015572
- 3030412764
- 1057425
- 1645151
- 1000550978
- 3010047402
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- 3008102042
- 1220246
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- 2030624
- 1720929
- 3004371426
- 3007366790
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- 3015207155
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- 9614209
- 3005718816
- 3035366890
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- 3011274144
- 3012319330
- 2249615
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- 1219602
- 1424263
- 3016851379
- 2528981
- 9616671
- 3003998208
- 3010375065
- 9613369
- 3005551626
- 3014302784
- 3008262872
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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