Strickland Trapezial Implant
FDA 510(k) K951471 · Wrightmedicaltechnologyinc
510(k) numberK951471
Submission
- Device name
- Strickland Trapezial Implant
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- March 30, 1995
- Decision date
- August 9, 1995
- 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 |
| 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 |
More from Nexa Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment SystemHSN · Traditional | 01/27/2023SE |
| K213342 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 01/05/2022SE |
| K212996 | Sterile PHALINX Hammertoe SystemHWC · Traditional | 11/16/2021SE |
| K202815 | PROPHECY Preoperative Navigation Alignment SystemHSN · Traditional | 03/10/2021SE |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemHRS · Traditional | 01/08/2021SE |
| K200507 | PRO-DENSE LoVisc Bone Graft SubstituteMQV · Traditional | 10/21/2020SE |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total…HSN · Traditional | 06/08/2020SE |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle SystemHSN · Traditional | 08/22/2019SE |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) SystemHWC · Traditional | 08/13/2019SE |
| K183620 | PROSTEP TBC Implant SystemHRS · Traditional | 06/06/2019SE |
Questions and answers
When was Strickland Trapezial Implant cleared by the FDA?
Strickland Trapezial Implant (K951471) received a 510(k) decision of Substantially Equivalent on August 9, 1995, 132 days after the submission was received.
What is the product code of K951471?
The FDA product code is KYI – Prosthesis, Wrist, Carpal Trapezium, a Class II (moderate risk) device regulated under 21 CFR 888.3770.