Pillar Nasal, Dorsal Columella and Nasal Dorsum Implants
FDA 510(k) K992242 · Pillar Surgical, Inc.
510(k) numberK992242
Submission
- Device name
- Pillar Nasal, Dorsal Columella and Nasal Dorsum Implants
- Applicant
- Pillar Surgical, Inc.
La Jolla, CA, US - Received
- July 2, 1999
- Decision date
- November 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FZE – Prosthesis, Nose, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3680
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241253 | Medicon Epiplating SystemFZE · Traditional | Cmf Medicon Surgical, Inc. | 12/12/2024SE |
| K161548 | Osseointegrated FixturesFZE · Traditional | Southern Implants (Pty), Ltd. | 12/01/2016SE |
| K090803 | Hanson Medical Facial ImplantsFZE · Traditional | Hanson Medical, Inc. | 06/30/2010SE |
| K090630 | Nobel Biocare Endosseous Implants (Maxillofacial Indication)FZE · Traditional | Nobel Biocare AB | 06/02/2009SE |
| K071018 | Monarch Nasal ImplantFZE · Traditional | Hanson Medical, Inc. | 05/25/2007SE |
| K041690 | Monarch Nasal ImplantFZE · Traditional | Hanson Medical, Inc. | 02/11/2005SE |
| K021418 | Aart Nasal ImplantFZE · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982753 | Seare Biomedical Nasal ImplantsFZE · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K981833 | Silimed Nasal L Shaped ImplantFZE · Traditional | Silimed, LLC | 06/26/1998SE |
More from Silimed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K002633 | Silmax Pectoral ImplantMIC · Traditional | 11/21/2000SE |
| K002629 | Silmax Contour Carving Block ImplantJOF · Traditional | 11/20/2000SE |
| K992240 | Pillar Malar ImplantLZK · Traditional | 11/22/1999SE |
| K992239 | Pillar Chin ImplantFWP · Traditional | 11/22/1999SE |
| K991970 | Scarease Sheets & Scarease GelMDA · Traditional | 10/25/1999SE |
| K954382 | Prolastic SheetingMIB · Traditional | 11/29/1995SE |
Questions and answers
When was Pillar Nasal, Dorsal Columella and Nasal Dorsum Implants cleared by the FDA?
Pillar Nasal, Dorsal Columella and Nasal Dorsum Implants (K992242) received a 510(k) decision of Substantially Equivalent on November 22, 1999, 143 days after the submission was received.
What is the product code of K992242?
The FDA product code is FZE – Prosthesis, Nose, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3680.