FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HARRINGTON SPINAL ELEVATOR
K Number: K781449
·
Decision Sep 27, 1978
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
11
Applicant Total
45
Review Days
35
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Basic Information
- Device Name
- HARRINGTON SPINAL ELEVATOR
- K Number
- K781449
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Orthopedic Equipment Co., Inc.
- Date Received
- August 23, 1978
- Decision Date
- September 27, 1978
- Product Code
- GEG
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEG | Elevator, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEG), ordered by most recent decision date.
ELEVATORS, VARIOUS TYPES
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SEPTUM ELEVATOR
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SURGICAL ELEVATOR
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LIGATURE NEEDLES
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1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS
FDA 510(k)
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·General, Plastic Surgery
Other Clearances by Orthopedic Equipment Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K834035 | UNIVERSAL SELF-ALIGNING ACETABULAR COM | Jun 19, 1984 | Substantially Equivalent |
| K841189 | OEC/REZAIAN SPINAL FIXATOR | May 16, 1984 | Substantially Equivalent |
| K800530 | SCHLEIN TRI-SURFACE ANKLE | Apr 2, 1980 | Substantially Equivalent |
| K781445 | SPREADER | Sep 27, 1979 | Substantially Equivalent |
| K790247 | TOURNIQUET TEST GAGE | Feb 26, 1979 | Substantially Equivalent |
| K790209 | FILTER SYSTEM, ALTNER DISPOSABLE | Feb 26, 1979 | Substantially Equivalent |
| K781450 | DRIVERS | Sep 27, 1978 | Substantially Equivalent |
| K781444 | OUTRIGGER DISTRACTION UNIT | Sep 27, 1978 | Substantially Equivalent |
| K781451 | FLAT WRENCH | Sep 27, 1978 | Substantially Equivalent |
| K781447 | THREADED ROD CLAMP | Sep 27, 1978 | Substantially Equivalent |