FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERAMIC TIPPED SKULL PIN
K Number: K040363
·
Decision Apr 12, 2004
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
8
Applicant Total
2
Review Days
59
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Basic Information
- Device Name
- CERAMIC TIPPED SKULL PIN
- K Number
- K040363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Jerome Group, Inc.
- Date Received
- February 13, 2004
- Decision Date
- April 12, 2004
- Product Code
- LYT
- 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 |
|---|---|---|---|
| LYT | Fixation Accessory | FDA class 2 | Orthopedic |
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Other Clearances by The Jerome Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023959 | JEROME GLASS RING | Feb 21, 2003 | Substantially Equivalent |