HANSON MEDICAL FACIAL IMPLANTS
FDA 510(k) clearance K090803 · decided 2010-06-30
Clearance details
- K-number
- K090803
- Device name
- HANSON MEDICAL FACIAL IMPLANTS
- Applicant
- Hanson Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-24
- Decision date
- 2010-06-30
- Days to decision
- 463 days
- Clearance type
- Traditional
- Product code
- FZE
- Device class
- 2
- Regulation number
- 878.3680
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kingston, WA, 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 |
|---|---|---|
| Medicon Epiplating System (K241253) | Cmf Medicon Surgical, Inc. | 2024-12-12 |
| Osseointegrated Fixtures (K161548) | Southern Implants (Pty), Ltd. | 2016-12-01 |
| NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) (K090630) | Nobel Biocare AB | 2009-06-02 |
| MONARCH NASAL IMPLANT (K071018) | Hanson Medical, Inc. | 2007-05-25 |
| MONARCH NASAL IMPLANT (K041690) | Hanson Medical, Inc. | 2005-02-11 |
| AART NASAL IMPLANT (K021418) | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
| PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (K992242) | Pillar Surgical, Inc. | 1999-11-22 |
| NASAL DORSAL SERIES (K983755) | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| SEARE BIOMEDICAL NASAL IMPLANTS (K982753) | Seare Biomedical Corp. | 1998-09-30 |
| SILIMED NASAL L SHAPED IMPLANT (K981833) | Silimed, LLC | 1998-06-26 |
| DURALASTIC ANATOMICAL NASAL IMPLANTS (K973573) | Hanson Medical, Inc. | 1997-11-13 |
| DURALASTIC ANATOMICAL NASAL IMPLANTS (K971481) | Allied Biomedical Corp. | 1997-07-18 |
Recalls involving this device
No recalls on record reference this clearance.