FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
K Number: K033112
·
Decision Nov 5, 2003
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
9
Review Days
36
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Basic Information
- Device Name
- WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
- K Number
- K033112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hand Biomechanics Lab, Inc.
- Date Received
- September 30, 2003
- Decision Date
- November 5, 2003
- 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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|---|---|---|---|
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| K181192 | PIP Fix | Oct 22, 2018 | Substantially Equivalent |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | Jan 9, 2008 | Substantially Equivalent |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | Jun 10, 2003 | Substantially Equivalent |
| K992970 | DIGIT WIDGET | Nov 8, 1999 | Substantially Equivalent |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | Feb 12, 1999 | Substantially Equivalent |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Dec 22, 1994 | Substantially Equivalent |