Link Acetabular Mesh
FDA 510(k) K844225 · Waldemar Link GmbH & Co. KG
510(k) numberK844225
Submission
- Device name
- Link Acetabular Mesh
- Applicant
- Waldemar Link GmbH & Co. KG
E. Hanover, NJ, US - Received
- November 1, 1984
- Decision date
- November 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Link Acetabular Mesh cleared by the FDA?
Link Acetabular Mesh (K844225) received a 510(k) decision of Substantially Equivalent on November 14, 1984, 13 days after the submission was received.
What is the product code of K844225?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.