FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
K Number: K980445
·
Decision May 6, 1998
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
65
Applicant Total
18
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
- K Number
- K980445
- 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
- Spectrum Designs, Inc.
- Date Received
- February 5, 1998
- Decision Date
- May 6, 1998
- 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.
MEDPOR Customized Implant Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FITme Customized Silicone Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Customized Contour Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Customized Contour Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Stryker CMF MEDPOR Priority Customized Implant Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Stryker CMF MEDPOR Customized Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Spectrum Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992522 | SPECTRUM DESIGNS SPECTRAGEL | Oct 26, 1999 | Substantially Equivalent |
| K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK | Oct 13, 1998 | Substantially Equivalent |
| K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | May 6, 1998 | Substantially Equivalent |
| K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | Apr 3, 1998 | Substantially Equivalent |
| K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | Mar 4, 1998 | Substantially Equivalent |
| K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | Mar 3, 1998 | Substantially Equivalent |
| K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | Mar 3, 1998 | Substantially Equivalent |