FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORTICAL BONE SCREWS
K Number: K872738
·
Decision Jul 30, 1987
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
17
Review Days
20
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Basic Information
- Device Name
- CORTICAL BONE SCREWS
- K Number
- K872738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Military Engineering, Inc.
- Date Received
- July 10, 1987
- Decision Date
- July 30, 1987
- 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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Other Clearances by Military Engineering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874335 | EXPLORER-DENTAL PROBER | Dec 29, 1987 | Substantially Equivalent |
| K873715 | BONE PIN CUTTER 18 | Oct 28, 1987 | Substantially Equivalent |
| K872842 | PIN, HIP, KNOWLES | Aug 7, 1987 | Substantially Equivalent |
| K871834 | DRILL, HAND, BONE, SMEDBERG | Jul 31, 1987 | Substantially Equivalent |
| K872091 | CURRETTES, ALVEOLAR (MOLT AND MILLER) | Jul 31, 1987 | Substantially Equivalent |
| K872609 | CURETTE SET, ANTRUM, COAKLEY | Jul 15, 1987 | Substantially Equivalent |
| K871818 | SPATULA, DENTAL, CEMENT | Jul 2, 1987 | Substantially Equivalent |
| K872092 | OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 | Jun 23, 1987 | Substantially Equivalent |
| K870590 | CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY | Apr 16, 1987 | Substantially Equivalent |
| K871195 | MALLET, BONE SURGERY, STAINLESS STEEL, 2LB. | Apr 6, 1987 | Substantially Equivalent |