FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPLINTS, FINGER/TOE
K Number: K770786
·
Decision May 18, 1977
Classifications
1
FEI Numbers
416
Registration Numbers
416
Same Product Code
35
Applicant Total
303
Review Days
16
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Basic Information
- Device Name
- SPLINTS, FINGER/TOE
- K Number
- K770786
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- May 2, 1977
- Decision Date
- May 18, 1977
- Product Code
- ILH
- 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 |
|---|---|---|---|
| ILH | Splint, Hand, And Components | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILH), ordered by most recent decision date.
SPLINT WOOD
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FINGER EXTENSION SPLINT
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FINGER FLEXION SPLINT
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UNIVERSAL WRIST SPLINT & FOREARM SPLINT
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FDA Class 1
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WRIST SUPPORT
FDA 510(k)
FDA Class 1
·Physical Medicine
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| K020541 | AGILITY ANKLE REVISION PROSTHESIS | May 20, 2002 | Substantially Equivalent |
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