FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ROPER-TUKE ELBOW
K Number: K873660
·
Decision Jan 6, 1988
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
26
Applicant Total
95
Review Days
118
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Basic Information
- Device Name
- ROPER-TUKE ELBOW
- K Number
- K873660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3160
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Orthopedic Systems, Inc.
- Date Received
- September 10, 1987
- Decision Date
- January 6, 1988
- Product Code
- JDB
- 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 |
|---|---|---|---|
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Orthopedic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Jan 22, 1996 | Substantially Equivalent |
| K920256 | SPINE MOTION ANALYZER WITH EMG | Aug 10, 1992 | Substantially Equivalent |
| K910736 | JACKSON MULTIPURPOSE OPERATING TABLE | May 21, 1991 | Substantially Equivalent |
| K910031 | PARK CITY SHOULDER POSITIONER | Jan 24, 1991 | Substantially Equivalent |
| K903938 | C FIT CUP | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K892503 | NUFFIELD TOTAL KNEE | May 4, 1990 | Substantially Equivalent for Some Indications |
| K896678 | SILICONE PLUG | Jan 30, 1990 | Substantially Equivalent |
| K894283 | COMPREHENSIVE SPINE MOTION ANALYZER | Jan 19, 1990 | Substantially Equivalent |
| K890498 | FREEMAN MODULAR HIP STEM RIDGED VERSION | Oct 13, 1989 | Substantially Equivalent for Some Indications |
| K890331 | FREEMAN TOTAL HIP SYSTEM RIDGED STEM | Oct 13, 1989 | Substantially Equivalent |