SILMAX CONTOUR CARVING BLOCK IMPLANT
FDA 510(k) clearance K002629 · decided 2000-11-20
Clearance details
- K-number
- K002629
- Device name
- SILMAX CONTOUR CARVING BLOCK IMPLANT
- Applicant
- Pillar Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-23
- Decision date
- 2000-11-20
- Days to decision
- 89 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
- La Jolla, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pillar Surgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| MEDPOR CUSTOMIZED SURGICAL IMPLANT (K083621) | Porex Surgical, Inc. | 2009-02-03 |
| 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.