FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI-FIX, HUMERAL NAIL
K Number: K991405
·
Decision Jun 29, 1999
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
37
Applicant Total
26
Review Days
68
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Basic Information
- Device Name
- OMNI-FIX, HUMERAL NAIL
- K Number
- K991405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Turnkey Intergration USA, Inc.
- Date Received
- April 22, 1999
- Decision Date
- June 29, 1999
- Product Code
- KTW
- 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 |
|---|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Turnkey Intergration USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990523 | B2C, ESPACE REVISION CUP SYSTEM | Apr 30, 1999 | Substantially Equivalent |
| K990307 | OMNI-FIX, NAIL SYSTEM | Apr 1, 1999 | Substantially Equivalent |
| K972411 | LINK CEMENT PLUG | Aug 29, 1997 | Substantially Equivalent |
| K970284 | ARTOS, DIPLOS SYSTEM | Apr 21, 1997 | Substantially Equivalent |
| K970084 | LINK CERCLAGE WIRE SYSTEM | Mar 13, 1997 | Substantially Equivalent |
| K953653 | LUBINUS SP II HIP SYSTEM | Nov 6, 1995 | Substantially Equivalent |
| K943986 | LINK ENDO MODEL REVISION CUP | Jul 5, 1995 | Substantially Equivalent |
| K951355 | LINK SADDLE PROTHESIS | May 25, 1995 | Substantially Equivalent |
| K950397 | SYSTEM 22 VALVE | Apr 14, 1995 | Substantially Equivalent |
| K940297 | UNIVERSAL WRIST | Feb 6, 1995 | Substantially Equivalent for Some Indications |