510(k) K031724
- Device
- SYNTHES SMALL COBINATION CLAMP-MR SAFE
- Applicant
- SYNTHES (USA)
- 510(k) number
- K031724
- Product code
- KTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-14
- Date received
- 2003-06-03
- 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
- No
Applicant Contact#
- Contact
- BONNIE SMITH
- Address
- 1690 Russell Rd. Paoli PA US 19301 19301
FDA Registration Numbers#
- 3044090645
- 1834331
- 3009746186
- 3006513362
- 3004188066
- 3010009693
- 1526534
- 2032521
- 3004513872
- 3012755988
- 3016438694
- 3017168764
- 1043534
- 3008534770
- 9614209
- 1828464
- 3005893246
- 3008951116
- 3010041993
- 3003935342
- 3006395932
- 1835296
- 3004176895
- 3008650117
- 3014937101
- 2532027
- 3015869121
- 3014128887
- 3010363503
- 3030966822
- 3009732568
- 1057425
- 8031020
- 8010177
- 3015877656
- 3009144915
- 3003236702
- 1822565
- 3008599979
- 3006801265
- 1833920
- 3013176080
- 9611863
- 3010303097
- 3011683674
- 3014129047
- 1835251
- 3009116370
- 3005497913
- 3010041430
- 3014315669
- 3023808054
- 1054811
- 3007366790
- 3011500362
- 3015869493
- 3011578810
- 3006001176
- 9615128
- 3009417901
- 3011276773
- 1424434
- 1424263
- 3013365802
- 3015398319
- 3031800723
- 9610612
- 1643264
- 3003249380
- 3009887475
- 3009540749
- 3010673850
- 8010916
- 3007738812
- 9616680
- 1000491390
- 8043862
- 3005061536
- 1818910
- 3006179046
Source Documents#
Other 510(k) Records For Product Code KTT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC | 2026-06-11 |
| K260900 | DYNEX® External Fixation Systems | Vilex, LLC | 2026-04-17 |
| K260112 | QuikFix External Fixator: Knee-Spanning Pack | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| K253291 | Excelsior System | Blue Ocean Global | 2026-01-20 |
| K253202 | Hoffmann LRF System | Stryker GmbH | 2025-12-19 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025-12-19 |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | 2025-11-25 |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | 2025-11-20 |
| K252106 | External Fixation Mini Rail System | Paragon 28, Inc. | 2025-09-30 |
| K251862 | External Fixation Bone Distractor | Paragon 28, Inc. | 2025-08-11 |
| K250472 | SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Amdt Holdings, Inc. | 2025-08-08 |
| K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-05-07 |
| K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025-03-07 |
| K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025-02-21 |
| K242861 | TrueLok Elevate | Orthofix Srl | 2024-12-03 |
Legacy Summary#
summary
FDA Review#
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