FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
K Number: K982354
·
Decision Nov 23, 1998
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
2
Review Days
140
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Basic Information
- Device Name
- SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
- K Number
- K982354
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Special Devices, Inc.
- Date Received
- July 6, 1998
- Decision Date
- November 23, 1998
- Product Code
- HTN
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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Other Clearances by Special Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050957 | EUTROCHAR | May 18, 2005 | Substantially Equivalent |