FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPLIT CERVICAL COLLAR/HEAD HALTER
K Number: K760869
·
Decision Nov 1, 1976
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
2
Applicant Total
45
Review Days
14
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Basic Information
- Device Name
- SPLIT CERVICAL COLLAR/HEAD HALTER
- K Number
- K760869
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.5890
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Orthopedic Equipment Co., Inc.
- Date Received
- October 18, 1976
- Decision Date
- November 1, 1976
- Product Code
- HSS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| HSS | Halter, Head, Traction | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSS), ordered by most recent decision date.
ORTHOPEDIC SOFT GOODS
FDA 510(k)
FDA Class 1
·Orthopedic
MEDISHIELD CERVICAL COLLAR
FDA 510(k)
FDA Class 1
·Orthopedic
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 |