Charlotte Compression Plate
FDA 510(k) K051908 · Wrightmedicaltechnologyinc
510(k) numberK051908
Submission
- Device name
- Charlotte Compression Plate
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- July 14, 2005
- Decision date
- August 10, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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Questions and answers
When was Charlotte Compression Plate cleared by the FDA?
Charlotte Compression Plate (K051908) received a 510(k) decision of Substantially Equivalent on August 10, 2005, 27 days after the submission was received.
What is the product code of K051908?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.