510(k) K241769
- Device
- Response Ortho Metaphyseal Hinge Fixator System
- Applicant
- Response Ortho Solutions, LLC
- 510(k) number
- K241769
- Product code
- KTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-18
- Date received
- 2024-06-20
- Regulation
- 888.3030
- Classification name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- 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
Related Records
Applicant Contact
- Contact
- Sehmuz Isin
- Address
- 1875 W Woolbright Rd. Boynton Beach FL US 33426 33426
FDA Registration Numbers
- 3015709929
- 1423662
- 1450662
- 2031910
- 9680619
- 1226074
- 3023808054
- 1649390
- 3009540749
- 3004176895
- 3013176080
- 3009350690
- 3021008900
- 3009973699
- 3007334927
- 1043534
- 3006801265
- 3004464325
- 1835831
- 3001239363
- 9681191
- 2183744
- 3010041430
- 3010368646
- 2183946
- 3023852420
- 1834331
- 1018470
- 3009513193
- 3015212339
- 3013194153
- 3011024991
- 1833824
- 3007420745
- 1833920
- 3025603301
- 2032521
- 3005061536
- 3034676720
- 3004142400
- 1643264
- 3006946279
- 3004358587
- 1043653
- 9680825
- 9610612
- 3002808145
- 2648920
- 3015882686
- 3007289093
- 3000327445
- 3014129047
- 3006460162
- 3009746186
- 2532027
- 3010120104
- 3007593722
- 3018269629
- 3017521423
- 3006395932
- 3009116370
- 3004976965
- 3010303097
- 3010287687
- 1424434
- 3002949614
- 3010123172
- 3006015326
- 3014680795
- 3013302242
- 3007923096
- 3010041993
- 8010177
- 3019767615
- 3010331645
- 3006694268
- 3011302692
- 3017980266
- 3016438694
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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