510(k) K221558
- Device
- ALPHALOK Plating System
- Applicant
- Vilex, LLC
- 510(k) number
- K221558
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-15
- Date received
- 2022-05-31
- Regulation
- 888.3030
- Classification name
- Plate, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Brock Johnson
- Address
- 111 Moffitt St. Mcminnville TN US 37110 37110
FDA Registration Numbers
- 1450662
- 3016778139
- 9680619
- 3030926959
- 3023808054
- 1649390
- 3015131017
- 1043534
- 3004464325
- 3001239363
- 1421101
- 3012086398
- 3023852420
- 1834331
- 3003541440
- 3013756169
- 3015075784
- 3005290844
- 3013194153
- 1833824
- 1313525
- 3015410662
- 1643264
- 3000170817
- 1319660
- 9611579
- 3017521423
- 2028523
- 3027339877
- 3002949614
- 9612277
- 3009756327
- 8010177
- 3010846112
- 2249697
- 3010863450
- 3019767615
- 3010331645
- 1531050
- 3008696586
- 3006128100
- 1225838
- 3002962587
- 3007648354
- 3010118938
- 1030489
- 3012478585
- 3017609305
- 3029933740
- 3017191784
- 2183449
- 2183967
- 1060840
- 3006001176
- 3005751028
- 3002807295
- 3009196021
- 1061927
- 3009189869
- 3009887475
- 9616680
- 1221053
- 3010047454
- 3016247852
- 3014315669
- 3009973505
- 8030965
- 3016761372
- 3012447612
- 3021336182
- 9610622
- 3006017180
- 3016237080
- 1835296
- 3009153862
- 1032347
- 3008599979
- 2029275
- 9615128
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