FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KRONNER SACRAL PIN GUIDE
K Number: K895172
·
Decision Sep 12, 1989
Classifications
1
FEI Numbers
1106
Registration Numbers
1106
Same Product Code
57
Applicant Total
7
Review Days
33
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Basic Information
- Device Name
- KRONNER SACRAL PIN GUIDE
- K Number
- K895172
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Kronner Medical
- Date Received
- August 10, 1989
- Decision Date
- September 12, 1989
- Product Code
- LXH
- 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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | FDA class 1 | Orthopedic |
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Other Clearances by Kronner Medical
| K Number | Device Name | ||
|---|---|---|---|
| K894228 | KRONNER SPHERICAL CUTTERS | Jul 23, 1990 | Substantially Equivalent |
| K895171 | BLOOD GAS SAFETY SYRINGE | Nov 7, 1989 | Substantially Equivalent |
| K895173 | SKELETAL FIXATION PIN | Sep 12, 1989 | Substantially Equivalent |
| K871248 | KRONNER COLLES-FOREARM EXTERNAL FIXATION | Jun 3, 1987 | Substantially Equivalent |
| K871249 | KRONNER BI-PLANER TIBIA EXTERNAL FIXATION | May 22, 1987 | Substantially Equivalent |
| K871247 | KRONNER UNIVERSAL FRAME EXTERNAL FIXATION | May 22, 1987 | Substantially Equivalent |