Ascension Nugrip CMC Implant
FDA 510(k) K112278 · Ascension Orthopedic
510(k) numberK112278
Submission
- Device name
- Ascension Nugrip CMC Implant
- Applicant
- Ascension Orthopedic
Austin, TX, US - Received
- August 9, 2011
- Decision date
- November 4, 2011
- 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 |
| 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 |
| K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40KYI · Traditional | Ascension Orthopedics, Inc. | 08/11/2006SE |
| 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 |
|---|---|---|
| K140463 | Integra External Fixation SystemKTT · Traditional | 10/10/2014SE |
| K131360 | Integra Titanium Bone WedgeHRS · Traditional | 08/07/2013SE |
| K130050 | Titan Reverse Shoulder SystemKWS · Traditional | 06/18/2013SE |
| K112438 | Titan Modular Total Shoulder SystemKWS · Special | 04/11/2012SE |
| K112481 | First Choice Druj System, Partial Head ImplantKXE · Traditional | 04/09/2012SE |
| K111799 | Nugait(Tm) Subtalar Implant SystemHWC · Traditional | 08/19/2011SE |
Questions and answers
When was Ascension Nugrip CMC Implant cleared by the FDA?
Ascension Nugrip CMC Implant (K112278) received a 510(k) decision of Substantially Equivalent on November 4, 2011, 87 days after the submission was received.
What is the product code of K112278?
The FDA product code is KYI – Prosthesis, Wrist, Carpal Trapezium, a Class II (moderate risk) device regulated under 21 CFR 888.3770.