FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OEC DESIGN ORTHOPEDIC CAST HEEL
K Number: K864092
·
Decision Dec 16, 1986
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
17
Review Days
56
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Basic Information
- Device Name
- OEC DESIGN ORTHOPEDIC CAST HEEL
- K Number
- K864092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5940
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Military Engineering, Inc.
- Date Received
- October 21, 1986
- Decision Date
- December 16, 1986
- Product Code
- LGF
- 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 |
|---|---|---|---|
| LGF | Component, Cast | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGF), ordered by most recent decision date.
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
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CARAPACE STERILE CAST PADDING
FDA 510(k)
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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 |
| K872738 | CORTICAL BONE SCREWS | Jul 30, 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 |