FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS
K Number: K860074
·
Decision Feb 11, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
24
Review Days
35
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Basic Information
- Device Name
- SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS
- K Number
- K860074
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Warsaw Orthopedic, Inc.
- Date Received
- January 7, 1986
- Decision Date
- February 11, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by Warsaw Orthopedic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892877 | CRADLE, HOSPITAL BED CLOTHING | Jun 15, 1989 | Substantially Equivalent |
| K883784 | TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE | Apr 6, 1989 | Substantially Equivalent for Some Indications |
| K883783 | TSRH SACRAL SPINAL SCREW | Apr 6, 1989 | Substantially Equivalent for Some Indications |
| K880211 | TSRH H/M HOOK HOLDER | Mar 4, 1988 | Substantially Equivalent |
| K880212 | TSRH H/M HOOK HOLDER W/ROD MOVER | Mar 4, 1988 | Substantially Equivalent |
| K880215 | TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD | Feb 18, 1988 | Substantially Equivalent |
| K880214 | TSRH H/M TORQUE LIMITING WRENCH | Feb 18, 1988 | Substantially Equivalent |
| K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP | May 27, 1987 | Substantially Equivalent |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | May 27, 1987 | Substantially Equivalent |
| K870830 | WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM | May 4, 1987 | Substantially Equivalent |