510(k) K242671
- Device
- Treace Medical Concepts (TMC) Screw Fixation System
- Applicant
- Treace Medical Concepts, Inc.
- 510(k) number
- K242671
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-04
- Date received
- 2024-09-06
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Melissa Coloroso
- Address
- 100 Palmetto Park Pl. Ponte Vedra FL US 32081 32081
FDA Registration Numbers
- 1450662
- 3026586698
- 3016778139
- 9680619
- 3030926959
- 3023808054
- 1649390
- 3015131017
- 3009394448
- 1043534
- 3004464325
- 2031917
- 3001239363
- 1421101
- 3015453963
- 2183744
- 8044172
- 3012086398
- 3023852420
- 1834331
- 3003541440
- 3013756169
- 3015075784
- 3005290844
- 3014522470
- 3013194153
- 1833824
- 2032521
- 2649614
- 2031093
- 3015410662
- 1643264
- 3004358587
- 1219655
- 3000170817
- 1319660
- 9611579
- 3017521423
- 3025114181
- 3003678543
- 1226183
- 3027339877
- 3002949614
- 1064858
- 3017210488
- 3007700286
- 3012429289
- 9612277
- 8010177
- 3010846112
- 2249697
- 3010863450
- 3019767615
- 3010331645
- 1531050
- 3008696586
- 3005029036
- 3006128100
- 2530154
- 1225838
- 3014279513
- 3027827832
- 3002962587
- 3010118938
- 3015173212
- 3012478585
- 3029933740
- 3006638824
- 3017191784
- 2183449
- 2183967
- 1060840
- 3008870565
- 3006001176
- 3002807295
- 3030514683
- 1061927
- 3009189869
- 3022518322
Source Documents
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| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 |
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