Biosponge Reconstruction Discs
FDA 510(k) K771727 · Xomed, Inc.
510(k) numberK771727
Submission
- Device name
- Biosponge Reconstruction Discs
- Applicant
- Xomed, Inc.
Arnold, MO, US - Received
- September 13, 1977
- Decision date
- September 26, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K171037 | PoreStar Patient Specific ImplantJOF · Traditional | Anatomics Pty, Ltd. | 12/27/2017SE |
| 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 |
| K771726 | Biosponge Stapes PistonJOF · Traditional | Xomed, Inc. | 09/26/1977SE |
More from Xomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | 12/11/2000SE |
| K002987 | Redtronic Xomed Monopolar Energized BladeGEI · Traditional | 12/04/2000SE |
| K002828 | XPS Nitro SystemERL · Traditional | 10/17/2000SE |
| K002897 | Titanium Middle Ear ProsthesesETB · Traditional | 10/11/2000SE |
| K993653 | Micro-France Trocars and AccessoriesHET · Traditional | 06/09/2000SE |
| K001148 | Merogel Otologic PackKHJ · Traditional | 06/03/2000SE |
| K994262 | Frontal Sinus Trephination CannulaKAM · Traditional | 02/08/2000SE |
| K992855 | XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptQPB · Traditional | 01/21/2000SE |
| K993582 | Modification to Laser-Shield IIBTR · Traditional | 01/20/2000SE |
| K993655 | Micro-France Electrosurgical Instruments, VariousGEI · Traditional | 12/21/1999SE |
Questions and answers
When was Biosponge Reconstruction Discs cleared by the FDA?
Biosponge Reconstruction Discs (K771727) received a 510(k) decision of Substantially Equivalent on September 26, 1977, 13 days after the submission was received.
What is the product code of K771727?
The FDA product code is JOF – Polymer, Ent Synthetic, Porous Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 874.3620.