FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEC ROD CONNECTOR
K Number: K850443
·
Decision Jul 15, 1985
Classifications
1
FEI Numbers
247
Registration Numbers
247
Same Product Code
392
Applicant Total
29
Review Days
160
Basic Information
- Device Name
- MEC ROD CONNECTOR
- K Number
- K850443
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- PFIZER, INC.
- Date Received
- February 5, 1985
- Decision Date
- July 15, 1985
- Product Code
- KTT
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
| K991620 | VISINE FOR CONTACTS | Sep 24, 1999 | Substantially Equivalent |
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| K892360 | WATER JEL STERILE GEL-SOAKED BURN DRESSING | Jun 5, 1989 | Substantially Equivalent |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | Jun 17, 1988 | Substantially Equivalent |
| K854726 | MEDI-WIPES UNITED ANTISEPTIC SKIN PREP | Feb 24, 1986 | Substantially Equivalent |
| K850413 | MEC HIP BOLT | Jul 15, 1985 | Substantially Equivalent |
| K850403 | MEC DISTAL FEMORAL BOLT | Jul 15, 1985 | Substantially Equivalent |
| K850840 | HOWMEDICA THREADED ACETABULAR COMPONENT | Jul 15, 1985 | Substantially Equivalent |
| K851971 | SERIES 7000/HOLTER RECORDER | Jun 20, 1985 | Substantially Equivalent |
| K852041 | DEKNATEL THORACIC CATHETER | Jun 17, 1985 | Substantially Equivalent |