510(k) K171037
- Device
- PoreStar Patient Specific Implant
- Applicant
- Anatomics Pty Ltd
- 510(k) number
- K171037
- Product code
- JOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-12-27
- Date received
- 2017-04-06
- Regulation
- 874.3620
- Classification name
- Polymer, Ent Synthetic, Porous Polyethylene
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joanne Flatley
- Address
- 23-27 Wellington St. St Kilda AU 3182 3182
FDA Registration Numbers#
- 2916714
- 8010177
Source Documents#
Other 510(k) Records For Product Code JOF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200532 | StarPore | Anatomics Pty, Ltd. | 2020-06-02 |
| K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | Porex Surgical, Inc. | 2009-02-03 |
| K002629 | SILMAX CONTOUR CARVING BLOCK IMPLANT | Pillar Surgical, Inc. | 2000-11-20 |
| K771726 | BIOSPONGE STAPES PISTON | Xomed, Inc. | 1977-09-26 |
| K771727 | BIOSPONGE RECONSTRUCTION DISCS | Xomed, Inc. | 1977-09-26 |
Legacy Summary#
summary
FDA Review#
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