FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K Number: K971047
·
Decision Jun 20, 1997
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
16
Review Days
91
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Basic Information
- Device Name
- FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
- K Number
- K971047
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3730
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexa Orthopedics, Inc.
- Date Received
- March 21, 1997
- Decision Date
- June 20, 1997
- Product Code
- KWD
- 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 |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K070688 | NEXFIX COMPRESSION STAPLE | May 18, 2007 | Substantially Equivalent |
| K060386 | NEXA CARPO METACARPAL IMPLANT | May 10, 2006 | Substantially Equivalent |
| K060071 | NEXA COMPRESSION SCREW | Jan 26, 2006 | Substantially Equivalent |
| K053408 | NEXA BONE PLATE AND SCREW SYSTEM | Dec 22, 2005 | Substantially Equivalent |
| K053394 | NEXA BONE SCREW SYSTEM | Dec 14, 2005 | Substantially Equivalent |
| K051740 | TAPERED COMPRESSION PIN | Sep 6, 2005 | Substantially Equivalent |
| K051406 | OSTEOCURE RESORBABLE BEAD KIT | Aug 1, 2005 | Substantially Equivalent |
| K033046 | SUBTALAR PEG IMPLANT | Dec 23, 2003 | Substantially Equivalent |