Implex Screw and Washer System
FDA 510(k) K982751 · Implex Corp.
510(k) numberK982751
Submission
- Device name
- Implex Screw and Washer System
- Applicant
- Implex Corp.
Allendale, NJ, US - Received
- August 6, 1998
- Decision date
- February 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Implex Screw and Washer System cleared by the FDA?
Implex Screw and Washer System (K982751) received a 510(k) decision of Substantially Equivalent on February 1, 1999, 179 days after the submission was received.
What is the product code of K982751?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.