FDA 510(k)
FDA class 2
Substantially Equivalent
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SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
K Number: K984543
·
Decision Mar 1, 1999
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
13
Review Days
70
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Basic Information
- Device Name
- SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
- K Number
- K984543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syntec Scientific Corp.
- Date Received
- December 21, 1998
- Decision Date
- March 1, 1999
- 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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| K090476 | SYNTEC ORTHODONTIC MINI SCREW | Jun 18, 2009 | Substantially Equivalent |
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| K984602 | SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM | Mar 5, 1999 | Substantially Equivalent |
| K984364 | SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 | Mar 2, 1999 | Substantially Equivalent |
| K983988 | SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE | Jan 27, 1999 | Substantially Equivalent |
| K983873 | SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM | Dec 30, 1998 | Substantially Equivalent |
| K983495 | SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 | Dec 16, 1998 | Substantially Equivalent |