FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMORAL INTRAMEDULLARY RODS
K Number: K926465
·
Decision Aug 25, 1993
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
52
Applicant Total
15
Review Days
244
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Basic Information
- Device Name
- FEMORAL INTRAMEDULLARY RODS
- K Number
- K926465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Osteo Systems, Inc.
- Date Received
- December 24, 1992
- Decision Date
- August 25, 1993
- Product Code
- JDS
- 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 |
|---|---|---|---|
| JDS | Nail, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Applied Osteo Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935383 | FEMROD AND FEMROD RECON INSERT | Mar 21, 1995 | Substantially Equivalent |
| K933995 | TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION | Jan 27, 1995 | Substantially Equivalent |
| K944501 | TRUE/FLEX INTRAMEDULLARY ROD END-CAP | Nov 28, 1994 | Substantially Equivalent |
| K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR | Oct 3, 1994 | Substantially Equivalent |
| K943160 | INTERFERENCE SCREW | Sep 30, 1994 | Substantially Equivalent for Some Indications |
| K934148 | TRUE/FLEX CLAVICLE RODS | Feb 22, 1994 | Substantially Equivalent |
| K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR | Feb 22, 1994 | Substantially Equivalent |
| K932853 | PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS | Feb 22, 1994 | Substantially Equivalent |
| K924656 | TRUE/ FLEX FIBULA RODS | Nov 24, 1992 | Substantially Equivalent |
| K924657 | TRUE/FLEX METATARSAL RODS | Nov 24, 1992 | Substantially Equivalent |