Colorado Therapeutics Xenograft Implant
FDA 510(k) K160181 · Colorado Therapeutics, LLC
510(k) numberK160181
Submission
- Device name
- Colorado Therapeutics Xenograft Implant
- Applicant
- Colorado Therapeutics, LLC
Broomfield, CO, US - Received
- January 27, 2016
- Decision date
- October 20, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code FTM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | Boston Scientific | 08/12/2026SE |
| K250598 | Endoform Reconstructive Template - PLGAFTM · Traditional | Aroa Biosurgery , Ltd. | 06/03/2025SE |
| K243595 | OviTex PRS (Long-Term Resorbable)FTM · Special | TELA Bio, Inc. | 12/19/2024SE |
| K233991 | CanGaroo RM Antibacterial EnvelopeFTM · Traditional | Elutia, Inc. | 06/14/2024SE |
| K241126 | OviTex PRSFTM · Special | TELA Bio, Inc. | 05/22/2024SE |
| K223052 | Peri-Guard and Supple Peri-GuardFTM · Traditional | Synovis Life Technologies, Inc. | 04/07/2023SE |
| K214070 | OviTex PRS (Long Term Resorbable)FTM · Traditional | Tela Bio | 03/21/2023SE |
| K213163 | VersaWrapFTM · Special | Alafair Biosciences, Inc. | 10/29/2021SE |
| K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…FTM · Special | Synovis Life Technologies. Inc. (A Subsidiary of… | 10/27/2021SE |
| K203496 | Nexo-Gide Bilayer Collagen MembraneFTM · Traditional | Geistlich Pharma AG | 07/14/2021SE |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K172937 | Colorado Therapeutics Xenograft ImplantFTM · Special | 10/25/2017SE |
Questions and answers
When was Colorado Therapeutics Xenograft Implant cleared by the FDA?
Colorado Therapeutics Xenograft Implant (K160181) received a 510(k) decision of Substantially Equivalent on October 20, 2016, 267 days after the submission was received.
What is the product code of K160181?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.