MEDPOR CUSTOMIZED SURGICAL IMPLANT
FDA 510(k) clearance K083621 · decided 2009-02-03
Clearance details
- K-number
- K083621
- Device name
- MEDPOR CUSTOMIZED SURGICAL IMPLANT
- Applicant
- Porex Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-12-08
- Decision date
- 2009-02-03
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JOF
- Device class
- 2
- Regulation number
- 874.3620
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Newnan, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| StarPore (K200532) | Anatomics Pty, Ltd. | 2020-06-02 |
| PoreStar Patient Specific Implant (K171037) | Anatomics Pty, Ltd. | 2017-12-27 |
| SILMAX CONTOUR CARVING BLOCK IMPLANT (K002629) | Pillar Surgical, Inc. | 2000-11-20 |
| BIOSPONGE STAPES PISTON (K771726) | Xomed, Inc. | 1977-09-26 |
| BIOSPONGE RECONSTRUCTION DISCS (K771727) | Xomed, Inc. | 1977-09-26 |
Recalls involving this device
No recalls on record reference this clearance.