Omni-Fix, Humeral Nail
FDA 510(k) K991405 · Turnkey Intergration USA, Inc.
510(k) numberK991405
Submission
- Device name
- Omni-Fix, Humeral Nail
- Applicant
- Turnkey Intergration USA, Inc.
Sarasota, FL, US - Received
- April 22, 1999
- Decision date
- June 29, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction SystemKTW · Traditional | Paonan Biotech Co., Ltd. | 06/20/2019SE |
| K171606 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. (Aos) | 06/22/2017SE |
| K170693 | Phantom Small Bone Intramedullary Nail SystemKTW · Traditional | Paragon 28, Inc. | 06/19/2017SE |
| K160409 | AOS Anterolateral Proximal Humeral PlateKTW · Special | Advanced Orthopaedic Solutions, Inc. | 03/15/2016SE |
| K122541 | Orthofix Contours Proimal Humeral Plate (PHP)KTW · Special | Orthofix Srl | 09/20/2012SE |
| K080590 | Aos Proximal Humeral PlateKTW · Traditional | Advanced Orthopaedic Solutions, Inc. | 05/06/2008SE |
| K080109 | Synthes (USA) Modular Blade Plate SystemKTW · Traditional | Synthes (Usa) | 03/20/2008SE |
| K062920 | Orthofix Titanium Humeral Plating System LSPKTW · Traditional | Orthofix Srl | 11/13/2006SE |
| K023360 | Leforte System Bone PlateKTW · Traditional | Jeil Medical Corporation | 10/25/2002SE |
| K012645 | Reprocessed Ebi External Fixation DevicesKTW · Traditional | Alliance Medical Corp. | 06/24/2002SE |
More from Alliance Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K990523 | B2C, Espace Revision Cup SystemLPH · Traditional | 04/30/1999SE |
| K990307 | Omni-Fix, Nail SystemKTW · Traditional | 04/01/1999SE |
| K972411 | Link Cement PlugLZN · Traditional | 08/29/1997SE |
| K970284 | Artos, Diplos SystemKWY · Traditional | 04/21/1997SE |
| K970084 | Link Cerclage Wire SystemJDQ · Traditional | 03/13/1997SE |
| K953653 | Lubinus SP II Hip SystemJDG · Traditional | 11/06/1995SE |
| K943986 | Link Endo Model Revision CupHRS · Traditional | 07/05/1995SE |
| K951355 | Link Saddle ProthesisKWL · Traditional | 05/25/1995SE |
| K950397 | System 22 ValveBYE · Traditional | 04/14/1995SE |
| K940297 | Universal WristJWI · Traditional | 02/06/1995SN |
Questions and answers
When was Omni-Fix, Humeral Nail cleared by the FDA?
Omni-Fix, Humeral Nail (K991405) received a 510(k) decision of Substantially Equivalent on June 29, 1999, 68 days after the submission was received.
What is the product code of K991405?
The FDA product code is KTW – Appliance, Fixation, Nail/Blade/Plate Combination, Single Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.