Kmedic Internal/External Fixation Devices
FDA 510(k) K070561 · Teleflex Medical
510(k) numberK070561
Submission
- Device name
- Kmedic Internal/External Fixation Devices
- Applicant
- Teleflex Medical
Bannockburn, IL, US - Received
- February 27, 2007
- Decision date
- May 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
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| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
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| 510(k) | Device | Decision |
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| K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTapeGAT · Traditional | 05/06/2026SE |
| K251054 | Hem-o-lok PurplePlus Large Polymer Ligating ClipsFZP · Traditional | 07/03/2025SE |
| K242495 | LMA Fastrach ETT SUBTR · Traditional | 04/29/2025SE |
| K243553 | QuikClot Control+ Hemostatic DevicePOD · Traditional | 03/18/2025SE |
| K241784 | Arrow® Nitinol WireDQX · Traditional | 09/18/2024SE |
| K233713 | Pilling Tracheostomy TubesBTO · Traditional | 03/22/2024SE |
| K232970 | Hem-o-lok® Ligating ClipsFZP · Traditional | 01/12/2024SE |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | 08/30/2023SE |
| K231924 | EZ-IO Intraosseous Vascular Access SystemFMI · Special | 07/25/2023SE |
Questions and answers
When was Kmedic Internal/External Fixation Devices cleared by the FDA?
Kmedic Internal/External Fixation Devices (K070561) received a 510(k) decision of Substantially Equivalent on May 25, 2007, 87 days after the submission was received.
What is the product code of K070561?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.