FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RONGUER-ORTHOPEDIC
K Number: K890166
·
Decision Feb 13, 1989
Classifications
1
FEI Numbers
1106
Registration Numbers
1106
Same Product Code
57
Applicant Total
14
Review Days
35
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
- RONGUER-ORTHOPEDIC
- K Number
- K890166
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Dhason Brothers, Inc.
- Date Received
- January 9, 1989
- Decision Date
- February 13, 1989
- Product Code
- LXH
- 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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXH), ordered by most recent decision date.
SX-One MicroKnife
FDA 510(k)
FDA Class 1
·Orthopedic
IMBIBE NEEDLE
FDA 510(k)
FDA Class 1
·Orthopedic
SELF RETAINING SOFT TISSUE RETRACTOR
FDA 510(k)
FDA Class 1
·Orthopedic
MICROPERFORATION INSTRUMENT
FDA 510(k)
FDA Class 1
·Orthopedic
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
FDA 510(k)
FDA Class 1
·Orthopedic
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Dhason Brothers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890160 | GOUGES FOR FEMORAL HEADS | Feb 13, 1989 | Substantially Equivalent |
| K890168 | RETRACTOR, SELF-RETAINING | Feb 13, 1989 | Substantially Equivalent |
| K890161 | THOMPSON TYPE RASP W/TOMMY BAR | Feb 13, 1989 | Substantially Equivalent |
| K890156 | IMPACTOR FOR FEMORAL HEAD | Feb 13, 1989 | Substantially Equivalent |
| K890162 | EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD | Feb 13, 1989 | Substantially Equivalent |
| K890163 | AUSTIN MOORE HALLOW CHISEL | Feb 13, 1989 | Substantially Equivalent |
| K890164 | HUDSON BRACE W/BURRS | Feb 13, 1989 | Substantially Equivalent |
| K890158 | RETRACTORS | Feb 13, 1989 | Substantially Equivalent |
| K890165 | FORCEPS-ORTHOPEDIC | Feb 13, 1989 | Substantially Equivalent |
| K890157 | FORCEPS | Feb 13, 1989 | Substantially Equivalent |