FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEC HIP BOLT
K Number: K850413
·
Decision Jul 15, 1985
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
30
Review Days
161
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
- MEC HIP BOLT
- K Number
- K850413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Pfizer, Inc.
- Date Received
- February 4, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTT), ordered by most recent decision date.
MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
DYNEX® External Fixation Systems
FDA 510(k)
FDA Class 2
·Orthopedic
QuikFix External Fixator: Knee-Spanning Pack
FDA 510(k)
FDA Class 2
·Orthopedic
Excelsior System
FDA 510(k)
FDA Class 2
·Orthopedic
Hoffmann LRF System
FDA 510(k)
FDA Class 2
·Orthopedic
Monkey Rings External Ring Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Pfizer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181102 | ThermaCare Quick Therapy TENS | Sep 15, 2018 | Substantially Equivalent |
| K991620 | VISINE FOR CONTACTS | Sep 24, 1999 | Substantially Equivalent |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | Jun 14, 1989 | Substantially Equivalent |
| 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 |
| K850403 | MEC DISTAL FEMORAL BOLT | Jul 15, 1985 | Substantially Equivalent |
| K850840 | HOWMEDICA THREADED ACETABULAR COMPONENT | Jul 15, 1985 | Substantially Equivalent |
| K850443 | MEC ROD CONNECTOR | Jul 15, 1985 | Substantially Equivalent |
| K851971 | SERIES 7000/HOLTER RECORDER | Jun 20, 1985 | Substantially Equivalent |