The Trabecular Metal Reconstruction System, Model 10-340-XXXXX
FDA 510(k) K040756 · Implex Corp.
510(k) numberK040756
Submission
- Device name
- The Trabecular Metal Reconstruction System, Model 10-340-XXXXX
- Applicant
- Implex Corp.
Allendale, NJ, US - Received
- March 24, 2004
- Decision date
- July 14, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 The Trabecular Metal Reconstruction System, Model 10-340-XXXXX cleared by the FDA?
The Trabecular Metal Reconstruction System, Model 10-340-XXXXX (K040756) received a 510(k) decision of Substantially Equivalent on July 14, 2004, 112 days after the submission was received.
What is the product code of K040756?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.