510(k) K771726
- Device
- BIOSPONGE STAPES PISTON
- Applicant
- Xomed, Inc.
- 510(k) number
- K771726
- Product code
- JOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-26
- Date received
- 1977-09-13
- 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
- Third party reviewed
- N
Applicant Contact#
- Address
- 1318 Lonedell Rd. Arnold MO US 63010 63010
FDA Registration Numbers#
- 2916714
- 8010177
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | Porex Surgical, Inc. | 2009-02-03 |
| K002629 | SILMAX CONTOUR CARVING BLOCK IMPLANT | Pillar Surgical, Inc. | 2000-11-20 |
| K771727 | BIOSPONGE RECONSTRUCTION DISCS | Xomed, Inc. | 1977-09-26 |