AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
FDA 510(k) clearance K141912 · decided 2014-10-29
Clearance details
- K-number
- K141912
- Device name
- AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
- Applicant
- Advanced Orthopaedic Solutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-15
- Decision date
- 2014-10-29
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Torrance, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| QuikFix External Fixator: Knee-Spanning Pack (K260112) | Stabiliz Orthopaedics, Inc. | 2026-03-23 |
| Excelsior System (K253291) | Blue Ocean Global | 2026-01-20 |
| Hoffmann LRF System (K253202) | Stryker GmbH | 2025-12-19 |
| Monkey Rings External Ring Fixation System (K253613) | Paragon 28, Inc. | 2025-12-19 |
| Medusa Orthopedics Boa External Fixation System (K252555) | Medusa Orthopedics, LLC | 2025-11-25 |
| The Response Ortho Smart Fixator - Hexapod System (K252625) | Response Ortho Solutions, LLC | 2025-11-20 |
| External Fixation Mini Rail System (K252106) | Paragon 28, Inc. | 2025-09-30 |
| External Fixation Bone Distractor (K251862) | Paragon 28, Inc. | 2025-08-11 |
| SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472) | Amdt Holdings, Inc. | 2025-08-08 |
| Extremity Medical External Fixation System (K251128) | Extremity Medical, LLC | 2025-05-07 |
Recalls involving this device
No recalls on record reference this clearance.