FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACROMED INTERBODY DEPTH GAUGES
K Number: K873191
·
Decision Sep 9, 1987
Classifications
1
FEI Numbers
372
Registration Numbers
372
Same Product Code
3
Applicant Total
111
Review Days
27
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Basic Information
- Device Name
- ACROMED INTERBODY DEPTH GAUGES
- K Number
- K873191
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4300
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Buckman Co., Inc.
- Date Received
- August 13, 1987
- Decision Date
- September 9, 1987
- Product Code
- HTJ
- 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 |
|---|---|---|---|
| HTJ | Gauge, Depth | FDA class 1 | Orthopedic |
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