FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
3M OSTEOTOMY GUIDE
K Number: K830360
·
Decision Mar 1, 1983
Classifications
1
FEI Numbers
434
Registration Numbers
434
Same Product Code
9
Applicant Total
331
Review Days
26
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Basic Information
- Device Name
- 3M OSTEOTOMY GUIDE
- K Number
- K830360
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- 3M Company
- Date Received
- February 3, 1983
- Decision Date
- March 1, 1983
- Product Code
- HWT
- 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 |
|---|---|---|---|
| HWT | Template | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWT), ordered by most recent decision date.
ORTHOPLAN
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ORTHODOC PREOPERATIVE PLANNER MODEL 500
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KRONNER SPHERICAL CUTTERS
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SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA
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ARTHROSCOPIC MENISCAL SUTURE SYSTEM
FDA 510(k)
FDA Class 1
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MOLDED POLYSULFONE TRIAL PROSTHESIS
FDA 510(k)
FDA Class 1
·Orthopedic
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