FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSSTAPLE, CRANIOFACIAL
K Number: K023488
·
Decision Oct 31, 2002
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
288
Applicant Total
7
Review Days
14
Basic Information
- Device Name
- OSSTAPLE, CRANIOFACIAL
- K Number
- K023488
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMEDICAL ENTERPRISES, INC
- Date Received
- October 17, 2002
- Decision Date
- October 31, 2002
- Product Code
- JEY
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by BIOMEDICAL ENTERPRISES, INC
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|---|---|---|---|
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| K133520 | HAMMERLOCK 2 | Jan 9, 2014 | Substantially Equivalent |
| K124022 | SPEED SHIFT | May 14, 2013 | Substantially Equivalent |
| K061385 | OSSTAPLE, OSSPLATE, OSSFORCE | May 30, 2007 | Substantially Equivalent |
| K023486 | OSSTAPLE, MAXILLOFACIAL | Oct 31, 2002 | Substantially Equivalent |