510(k) K253291
- Device
- Excelsior System
- Applicant
- Blue Ocean Global
- 510(k) number
- K253291
- Product code
- KTT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-20
- Date received
- 2025-09-29
- 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
Applicant Contact#
- Contact
- Scott Ludecker
- Address
- 12550 Biscayne Blvd. Suite 110 Miami FL US 33181 33181
FDA Registration Numbers#
- 3009888740
- 9680619
- 3014315560
- 3005497913
- 1000491390
- 3011500362
- 3015356625
- 3013302242
- 2031910
- 3010047454
- 1226544
- 3000327445
- 3011276773
- 1833986
- 1220246
- 9681465
- 3032391
- 3009116370
- 3034676720
- 3004499989
- 3004188066
- 3010673850
- 3010667733
- 3014128887
- 1834331
- 3010178296
- 3003761012
- 3006783837
- 3015398319
- 3018269629
- 2027148
- 8010916
- 3003236702
- 3022142628
- 3019767615
- 3009973336
- 3014302784
- 3025603301
- 9615128
- 3013194153
- 3006015326
- 3010390570
- 1060840
- 3006395932
- 9613369
- 3016084569
- 1526534
- 1043534
- 3034525
- 3015869492
- 3007334927
- 3010120326
- 3014315669
- 3007738812
- 3006694268
- 3012711663
- 3014680795
- 3015946784
- 3009971621
- 3023808054
- 1833824
- 2134947
- 3013055499
- 3031800723
- 9611863
- 3008599979
- 3015869121
- 3028117759
- 1835572
- 3004464325
- 3038503932
- 3043355196
- 8031020
- 3003847101
- 2532027
- 3009417901
- 3015869493
- 3007593722
- 1051526
- 3007539489
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 |
| 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 |
| K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024-11-01 |