Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws
FDA 510(k) K082516 · Smith & Nephew, Inc.
510(k) numberK082516
Submission
- Device name
- Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- September 2, 2008
- Decision date
- September 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws cleared by the FDA?
Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws (K082516) received a 510(k) decision of Substantially Equivalent on September 17, 2008, 15 days after the submission was received.
What is the product code of K082516?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.