FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZYMALAR IMPLANT
K Number: K902284
·
Decision Sep 12, 1990
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
39
Applicant Total
7
Review Days
113
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Basic Information
- Device Name
- ZYMALAR IMPLANT
- K Number
- K902284
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Applied Biomaterial Technologies
- Date Received
- May 22, 1990
- Decision Date
- September 12, 1990
- Product Code
- LZK
- 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 |
|---|---|---|---|
| LZK | Implant, Malar | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZK), ordered by most recent decision date.
AART MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILLAR MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGIFORM ANATOMICAL MALAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEARE BIOMEDICAL MALAR IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SILIMED MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Applied Biomaterial Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K945552 | DURALASTIC SHEETING | Jan 31, 1995 | Substantially Equivalent |
| K935571 | DURALASTIC SHEETING | Jan 31, 1995 | Substantially Equivalent |
| K931500 | THE PERMARIDGE MATRIX CHIN | Nov 17, 1994 | Substantially Equivalent |
| K913768 | PEC IMPLANT | Feb 3, 1992 | Substantially Equivalent |
| K902285 | THE MAGNUM CHIN IMPLANT | Sep 12, 1990 | Substantially Equivalent |
| K902283 | THE NAUTILUS NASAL IMPLANT | Aug 14, 1990 | Substantially Equivalent |