Mecron(R) Acetabular Nets TM
FDA 510(k) K820619 · Serrano Intl.
510(k) numberK820619
Submission
- Device name
- Mecron(R) Acetabular Nets TM
- Applicant
- Serrano Intl.
Mchenry, IL, US - Received
- March 8, 1982
- Decision date
- May 14, 1982
- 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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| K851409 | Uniloc Total Hip Prosthesis · Traditional | 11/22/1985SE |
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Questions and answers
When was Mecron(R) Acetabular Nets TM cleared by the FDA?
Mecron(R) Acetabular Nets TM (K820619) received a 510(k) decision of Substantially Equivalent on May 14, 1982, 67 days after the submission was received.
What is the product code of K820619?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.