GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
FDA 510(k) K151037 · Conmed Corporation
510(k) numberK151037
Submission
- Device name
- GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
- Applicant
- Conmed Corporation
Utica, NY, US - Received
- April 20, 2015
- Decision date
- July 9, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle cleared by the FDA?
GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle (K151037) received a 510(k) decision of Substantially Equivalent on July 9, 2015, 80 days after the submission was received.
What is the product code of K151037?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.