Locon-T Distal Radial Plate
FDA 510(k) K994061 · Wrightmedicaltechnologyinc
510(k) numberK994061
Submission
- Device name
- Locon-T Distal Radial Plate
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- December 1, 1999
- Decision date
- February 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
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| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
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| 510(k) | Device | Decision |
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| K202815 | PROPHECY Preoperative Navigation Alignment SystemHSN · Traditional | 03/10/2021SE |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemHRS · Traditional | 01/08/2021SE |
| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle SystemHSN · Traditional | 08/22/2019SE |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) SystemHWC · Traditional | 08/13/2019SE |
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Questions and answers
When was Locon-T Distal Radial Plate cleared by the FDA?
Locon-T Distal Radial Plate (K994061) received a 510(k) decision of Substantially Equivalent on February 14, 2000, 75 days after the submission was received.
What is the product code of K994061?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.