Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
FDA 510(k) K061451 · Ascension Orthopedics, Inc.
510(k) numberK061451
Submission
- Device name
- Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
- Applicant
- Ascension Orthopedics, Inc.
Austin, TX, US - Received
- May 25, 2006
- Decision date
- August 11, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYI – Prosthesis, Wrist, Carpal Trapezium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3770
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KYI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161KYI · Traditional | Ensemble Orthopedics, LLC | 12/02/2020SE |
| K180744 | Stablyx CMC Arthroplasty Implant SystemKYI · Special | Skeletal Dynamics, LLC | 04/11/2018SE |
| K111068 | Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5KYI · Traditional | Skeletal Dynamics, LLC | 12/30/2011SE |
| K112278 | Ascension Nugrip CMC ImplantKYI · Traditional | Ascension Orthopedic | 11/04/2011SE |
| K092548 | Extremity Medical Trapezium ProsthesisKYI · Traditional | Extremity Medical, LLC | 12/15/2009SE |
| K061956 | Artelon STT SpacerKYI · Traditional | Artimplant AB | 06/07/2007SE |
| K061954 | Artelon CMC Spacer ArthroKYI · Special | Artimplant AB | 06/01/2007SE |
| K061089 | Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599KYI · Traditional | Biopro, Inc. | 06/20/2006SE |
| K060386 | Nexa Carpo Metacarpal ImplantKYI · Traditional | Nexa Orthopedics, Inc. | 05/10/2006SE |
| K052596 | Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240…KYI · Traditional | Biopro, Inc. | 11/15/2005SE |
More from Biopro, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233674 | Freedom Wrist Arthroplasty SystemJWJ · Traditional | 05/30/2024SE |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIPKYJ · Special | 12/14/2023SE |
| K182878 | Integra Salto Total Ankle SystemHSN · Special | 12/18/2018SE |
| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation SystemHWC · Traditional | 07/14/2017SE |
| K160830 | Integra External Fixation SystemKTT · Special | 07/06/2016SE |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS · Traditional | 12/23/2015SE |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC · Traditional | 10/29/2015SE |
| K151459 | Integra Total Ankle Replacement SystemHSN · Traditional | 08/31/2015SE |
| K142413 | TITAN Modular Total Shoulder SystemKWS · Traditional | 11/14/2014SE |
| K121826 | Integra Proximal Humeral Plate SystemHRS · Traditional | 02/13/2013SE |
Questions and answers
When was Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 cleared by the FDA?
Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (K061451) received a 510(k) decision of Substantially Equivalent on August 11, 2006, 78 days after the submission was received.
What is the product code of K061451?
The FDA product code is KYI – Prosthesis, Wrist, Carpal Trapezium, a Class II (moderate risk) device regulated under 21 CFR 888.3770.