GAMMA3 and T2 Recon Targeting Devices
FDA 510(k) K123401 · Stryker Trauma AG
510(k) numberK123401
Submission
- Device name
- GAMMA3 and T2 Recon Targeting Devices
- Applicant
- Stryker Trauma AG
Mahwah, NJ, US - Received
- November 5, 2012
- Decision date
- January 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…HSB · Traditional | 06/06/2018SE |
| K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemHSB · Traditional | 01/12/2018SE |
| K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…KWS · Traditional | 10/02/2017SE |
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| K153154 | Asnis JFX SystemHWC · Traditional | 12/28/2015SE |
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Questions and answers
When was GAMMA3 and T2 Recon Targeting Devices cleared by the FDA?
GAMMA3 and T2 Recon Targeting Devices (K123401) received a 510(k) decision of Substantially Equivalent on January 23, 2013, 79 days after the submission was received.
What is the product code of K123401?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.