FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
K Number: K852020
·
Decision May 22, 1985
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
24
Review Days
14
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Basic Information
- Device Name
- INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
- K Number
- K852020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Warsaw Orthopedic, Inc.
- Date Received
- May 8, 1985
- Decision Date
- May 22, 1985
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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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 |