FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMA LOCKING NAIL MODIFICATION
K Number: K940286
·
Decision Mar 14, 1994
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
36
Review Days
63
Basic Information
- Device Name
- GAMMA LOCKING NAIL MODIFICATION
- K Number
- K940286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica, Inc.
- Date Received
- January 10, 1994
- Decision Date
- March 14, 1994
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Howmedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K983358 | G/K SFN AND STN LOCKING NAILS | Nov 18, 1998 | Substantially Equivalent |
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| K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS | Jun 26, 1998 | Substantially Equivalent |
| K981283 | ROGACHEFSKY DISTAL RADIUS PLATES | Jun 10, 1998 | Substantially Equivalent |
| K980843 | EXETER INTRAMEDULLARY BONE PLUG | Jun 2, 1998 | Substantially Equivalent |