PoreStar Patient Specific Implant
FDA 510(k) K171037 · Anatomics Pty, Ltd.
510(k) numberK171037
Submission
- Device name
- PoreStar Patient Specific Implant
- Applicant
- Anatomics Pty, Ltd.
St Kilda, AU - Received
- April 6, 2017
- Decision date
- December 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOF – Polymer, Ent Synthetic, Porous Polyethylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code JOF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200532 | StarPoreJOF · Traditional | Anatomics Pty, Ltd. | 06/02/2020SE |
| K083621 | Medpor Customized Surgical ImplantJOF · Traditional | Porex Surgical, Inc. | 02/03/2009SE |
| K002629 | Silmax Contour Carving Block ImplantJOF · Traditional | Pillar Surgical, Inc. | 11/20/2000SE |
| K771727 | Biosponge Reconstruction DiscsJOF · Traditional | Xomed, Inc. | 09/26/1977SE |
| K771726 | Biosponge Stapes PistonJOF · Traditional | Xomed, Inc. | 09/26/1977SE |
More from Xomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200532 | StarPoreJOF · Traditional | 06/02/2020SE |
Questions and answers
When was PoreStar Patient Specific Implant cleared by the FDA?
PoreStar Patient Specific Implant (K171037) received a 510(k) decision of Substantially Equivalent on December 27, 2017, 265 days after the submission was received.
What is the product code of K171037?
The FDA product code is JOF – Polymer, Ent Synthetic, Porous Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 874.3620.