FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
DEPUY LOW PROFILE BONE SCREW
K Number: K970929
·
Decision Jun 9, 1997
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
1040
Applicant Total
303
Review Days
88
Basic Information
- Device Name
- DEPUY LOW PROFILE BONE SCREW
- K Number
- K970929
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- DEPUY, INC.
- Date Received
- March 13, 1997
- Decision Date
- June 9, 1997
- 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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