510(k) K141027
- Device
- 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
- Applicant
- IMPLANTECH ASSOCIATES INC.
- 510(k) number
- K141027
- Product code
- FWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-10
- Date received
- 2014-04-22
- Regulation
- 878.3550
- Classification name
- Prosthesis, Chin, Internal
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN MEADE
- Address
- 6025 Nicolle St., Suite B Ventura CA US 93003 93003
FDA Registration Numbers#
- 1047843
- 8010177
- 3003897287
- 3010781616
- 1825527
- 1018470
- 1032347
- 3013944123
- 2953359
- 2249697
- 2028924
- 2029275
- 2031444
- 2090040
Source Documents#
Other 510(k) Records For Product Code FWP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2026-03-12 |
| K232593 | FITme Customized Silicone Implant | Keosan Trading Co. | 2023-11-22 |
| K200610 | Customized Contour Implant | Implantech Associates, Inc. | 2020-12-23 |
| K191130 | Customized Contour Implant | Implantech Associates, Inc. | 2019-08-23 |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2019-08-15 |
| K153508 | Stryker CMF MEDPOR Customized Implant | Stryker | 2016-02-05 |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant | Poriferous, LLC | 2016-01-20 |
| K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015-03-23 |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | Howmedica Osteonics Corp. | 2012-11-01 |
| K091011 | PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) | Surgical Technology Laboratories, Inc ("Stl") | 2009-04-22 |
| K021417 | AART CHIN IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
| K012350 | MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL | Porex Surgical, Inc. | 2002-03-14 |
| K992239 | PILLAR CHIN IMPLANT | Pillar Surgical, Inc. | 1999-11-22 |
| K983754 | STANDARD CHIN | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| K982752 | SEARE BIOMEDICAL CHIN IMPLANTS | Seare Biomedical Corp. | 1998-09-30 |
Legacy Summary#
summary
FDA Review#
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