510(k) K083621
- Device
- MEDPOR CUSTOMIZED SURGICAL IMPLANT
- Applicant
- POREX SURGICAL, INC.
- 510(k) number
- K083621
- Product code
- JOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-03
- Date received
- 2008-12-08
- 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
- JERRI L MANN
- Address
- 15 Dart Rd. Newnan GA US 30265 30265
FDA Registration Numbers#
- 8010177
- 2916714
Source Documents#
Other 510(k) Records For Product Code JOF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200532 | StarPore | Anatomics Pty, Ltd. | 2020-06-02 |
| K171037 | PoreStar Patient Specific Implant | Anatomics Pty, Ltd. | 2017-12-27 |
| 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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