FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420
K Number: K983495
·
Decision Dec 16, 1998
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
13
Review Days
72
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Basic Information
- Device Name
- SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420
- K Number
- K983495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syntec Scientific Corp.
- Date Received
- October 5, 1998
- Decision Date
- December 16, 1998
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K092889 | SYNTEC OSTEO-PLATE AND SCREW FIXATION | Jun 25, 2010 | Substantially Equivalent |
| K090476 | SYNTEC ORTHODONTIC MINI SCREW | Jun 18, 2009 | Substantially Equivalent |
| K090839 | MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS | Apr 24, 2009 | Substantially Equivalent |
| K984602 | SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM | Mar 5, 1999 | Substantially Equivalent |
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| K984543 | SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 | Mar 1, 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 |