Depuy Neuflex Pip Finger
FDA 510(k) K001922 · Depuy, Inc.
510(k) numberK001922
Submission
- Device name
- Depuy Neuflex Pip Finger
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- June 23, 2000
- Decision date
- August 29, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYJ – Prosthesis, Finger, Constrained, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3230
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KYJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233670 | Ascension Silicone MCP; Ascension Silicone PIPKYJ · Special | Ascension Orthopedics, Inc. | 12/14/2023SE |
| K220142 | BRM Digitalis SpacerKYJ · Traditional | Brm Extremities Srl | 04/04/2023SE |
| K211385 | KeriFlex® MCP and PIP Finger Joint ProsthesesKYJ · Traditional | Keri Medical SA | 07/27/2022SE |
| K140453 | Osteotec Silicone Finger ImplantKYJ · Traditional | Osteotec, Ltd. | 04/17/2015SE |
| K083107 | Modification to Depuy Neuflex Pip FingerKYJ · Traditional | DePuy Orthopaedics, Inc. | 02/09/2009SE |
| K082231 | Ascension Silicone PipKYJ · Traditional | Ascension Orthopedics, Inc. | 01/12/2009SE |
| K022892 | Ascension Sillicone MCPKYJ · Traditional | Ascension Orthopedics, Inc. | 11/25/2002SE |
| K013629 | Finger Joint ProsthesisKYJ · Traditional | Avanta Orthopaedics, Inc. | 01/25/2002SE |
| K970544 | Depuy Dupont Orthopaedics Finger Joint ProsthesisKYJ · Traditional | Depuy, Inc. | 09/12/1997SE |
| K931588 | Sutter Proximal Interphalangeal JointKYJ · Traditional | Sutter Corp. | 03/10/1994SE |
More from Sutter Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K043058 | Pinnacle Constrained Acetabular LinersKWZ · Traditional | 03/14/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | 12/08/2004SE |
| K041085 | LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryJWH · Traditional | 07/22/2004SE |
| K033959 | LPSJWH · Traditional | 07/01/2004SE |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
| K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional | 09/07/2001SE |
Questions and answers
When was Depuy Neuflex Pip Finger cleared by the FDA?
Depuy Neuflex Pip Finger (K001922) received a 510(k) decision of Substantially Equivalent on August 29, 2000, 67 days after the submission was received.
What is the product code of K001922?
The FDA product code is KYJ – Prosthesis, Finger, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3230.