PriMatrix Dermal Repair Scaffold
FDA 510(k) K153690 · Tei Biosciences, Inc.
510(k) numberK153690
Submission
- Device name
- PriMatrix Dermal Repair Scaffold
- Applicant
- Tei Biosciences, Inc.
Boston, MD, US - Received
- December 23, 2015
- Decision date
- February 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code KGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260652 | ColActive PlusKGN · Traditional | Covalon Technologies, Ltd. | 09/09/2026SE |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | Berkeley Advanced Biomaterials | 08/27/2026SE |
| K260596 | Collagen Wound PowderKGN · Traditional | Ventris Medical | 07/02/2026SE |
| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
| K253521 | ECMT-100 WMDKGN · Traditional | Ecm Therapeutics, Inc. | 06/18/2026SE |
| K253204 | CatalyzeKGN · Traditional | BioTissue Holdings, Inc. | 06/05/2026SE |
| K254034 | Roosin Collagen PowderKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K253974 | Roosin Collagen DressingKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K261224 | MatriDermKGN · Special | Medskin Solutions Dr. Suwelack AG | 05/14/2026SE |
| K260532 | Derma-GideKGN · Special | Geistlich Pharma AG | 03/19/2026SE |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K162965 | SurgiMend MP Collagen Matrix for Soft Tissue ReconstructionFTM · Traditional | 02/16/2017SE |
| K131286 | Primatrix Dermal Repair ScaffoldKGN · Traditional | 08/05/2013SE |
| K100261 | Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldFRO · Abbreviated | 12/10/2010SE |
| K083898 | SurgimendFTM · Special | 02/04/2009SE |
| K083440 | Primatrix Dermal Repair ScaffoldKGN · Special | 12/12/2008SE |
| K071807 | Orthomend Soft Tissue MatrixFTM · Special | 08/06/2007SE |
| 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 PriMatrix Dermal Repair Scaffold cleared by the FDA?
PriMatrix Dermal Repair Scaffold (K153690) received a 510(k) decision of Substantially Equivalent on February 22, 2016, 61 days after the submission was received.
What is the product code of K153690?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.