Orthomend Soft Tissue Matrix
FDA 510(k) K071807 · Tei Biosciences, Inc.
510(k) numberK071807
Submission
- Device name
- Orthomend Soft Tissue Matrix
- Applicant
- Tei Biosciences, Inc.
Boston, MA, US - Received
- July 2, 2007
- Decision date
- August 6, 2007
- 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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| K083898 | SurgimendFTM · Special | 02/04/2009SE |
| K083440 | Primatrix Dermal Repair ScaffoldKGN · Special | 12/12/2008SE |
| K061407 | Primatrix Dermal Repair ScaffoldKGN · Special | 06/29/2006SE |
| K060984 | Xenform Soft Tissue Repair MatrixFTM · Special | 05/17/2006SE |
| K060829 | CosmatrixFTM · Abbreviated | 05/17/2006SE |
| K060989 | Tissuemend Soft Tissue Repair MatrixFTM · Special | 05/15/2006SE |
Questions and answers
When was Orthomend Soft Tissue Matrix cleared by the FDA?
Orthomend Soft Tissue Matrix (K071807) received a 510(k) decision of Substantially Equivalent on August 6, 2007, 35 days after the submission was received.
What is the product code of K071807?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.