Modification to Depuy Neuflex Pip Finger
FDA 510(k) K083107 · DePuy Orthopaedics, Inc.
510(k) numberK083107
Submission
- Device name
- Modification to Depuy Neuflex Pip Finger
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- October 20, 2008
- Decision date
- February 9, 2009
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K001922 | Depuy Neuflex Pip FingerKYJ · Traditional | Depuy, Inc. | 08/29/2000SE |
| K970544 | Depuy Dupont Orthopaedics Finger Joint ProsthesisKYJ · Traditional | Depuy, Inc. | 09/12/1997SE |
| K931588 | Sutter Proximal Interphalangeal JointKYJ · Traditional | Sutter Corp. | 03/10/1994SE |
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Questions and answers
When was Modification to Depuy Neuflex Pip Finger cleared by the FDA?
Modification to Depuy Neuflex Pip Finger (K083107) received a 510(k) decision of Substantially Equivalent on February 9, 2009, 112 days after the submission was received.
What is the product code of K083107?
The FDA product code is KYJ – Prosthesis, Finger, Constrained, Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3230.