FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPREADER BARS
K Number: K780226
·
Decision Feb 17, 1978
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
14
Applicant Total
441
Review Days
8
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Basic Information
- Device Name
- SPREADER BARS
- K Number
- K780226
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Biomet, Inc.
- Date Received
- February 9, 1978
- Decision Date
- February 17, 1978
- Product Code
- ILZ
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| ILZ | Accessories, Traction | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILZ), ordered by most recent decision date.
FLEXION DISTRATION SUPPORT
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VIBRA-TRAC TRACTION TABLE
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AMX-110, AMX-II AND AMX-III
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FDA Class 1
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VECTOR BAR SUSPENSION/TRACTION UNIT
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TRACTION ACCESSORIES
FDA 510(k)
FDA Class 1
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SAUNDERS #7080 CERVICAL TRACTION SYS
FDA 510(k)
FDA Class 1
·Physical Medicine
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