FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Customized Contour Implant
K Number: K191130
·
Decision Aug 23, 2019
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
65
Applicant Total
41
Review Days
116
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Basic Information
- Device Name
- Customized Contour Implant
- K Number
- K191130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implantech Associates, Inc.
- Date Received
- April 29, 2019
- Decision Date
- August 23, 2019
- Product Code
- FWP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWP), ordered by most recent decision date.
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Stryker CMF MEDPOR Priority Customized Implant Kit
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Stryker CMF MEDPOR Customized Implant
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SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Implantech Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200610 | Customized Contour Implant | Dec 23, 2020 | Substantially Equivalent |
| K172389 | ePTFE-Coated Auricular Implant | Jul 18, 2018 | Substantially Equivalent |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | Jul 10, 2014 | Substantially Equivalent |
| K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX | Aug 31, 2007 | Substantially Equivalent |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | Nov 4, 2005 | Substantially Equivalent |
| K052505 | CALF IMPLANT, MODEL EC17-X | Nov 4, 2005 | Substantially Equivalent |
| K013732 | GELZONE | Feb 7, 2002 | Substantially Equivalent |
| K012419 | CONFORM SHEETING, MODEL IGEL | Oct 24, 2001 | Substantially Equivalent |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Nov 24, 2000 | Substantially Equivalent |
| K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | Nov 7, 1997 | Substantially Equivalent |