Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
FDA 510(k) K170763 · Acell, Inc.
510(k) numberK170763
Submission
- Device name
- Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
- Applicant
- Acell, Inc.
Columbia, MD, US - Received
- March 13, 2017
- Decision date
- June 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend cleared by the FDA?
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend (K170763) received a 510(k) decision of Substantially Equivalent on June 8, 2017, 87 days after the submission was received.
What is the product code of K170763?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.