Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
FDA 510(k) K061089 · Biopro, Inc.
510(k) numberK061089
Submission
- Device name
- Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
- Applicant
- Biopro, Inc.
Port Huron, MI, US - Received
- April 18, 2006
- Decision date
- June 20, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K061451 | Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40KYI · Traditional | Ascension Orthopedics, Inc. | 08/11/2006SE |
| 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 |
|---|---|---|
| K163627 | Shotel Ankle Arthrodesis Nail SystemHSB · Traditional | 09/14/2017SE |
| K162674 | BioPro Foot Plating SystemsHRS · Traditional | 06/16/2017SE |
| K132510 | Biopro - Infinity Plate Anchor SystemHTN · Traditional | 10/24/2013SE |
| K130298 | Biopro Kwick-Wire Universal Screw SystemJDW · Traditional | 06/18/2013SE |
| K121973 | Biopro Hemi-Edge Toe SystemKWD · Traditional | 10/30/2012SE |
| K100761 | Biopro Polar HeadKWY · Traditional | 12/03/2010SE |
| K101030 | Modification to HBS Headless Bone ScrewHWC · Special | 06/03/2010SE |
| K090208 | Biopro Femoral HeadsJDI · Traditional | 05/22/2009SE |
| K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685HTY · Traditional | 03/18/2009SE |
| K082705 | Biopro Bipolar Head, Models 18130-18152KWY · Traditional | 12/15/2008SE |
Questions and answers
When was Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 cleared by the FDA?
Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 (K061089) received a 510(k) decision of Substantially Equivalent on June 20, 2006, 63 days after the submission was received.
What is the product code of K061089?
The FDA product code is KYI – Prosthesis, Wrist, Carpal Trapezium, a Class II (moderate risk) device regulated under 21 CFR 888.3770.