FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEXA BONE SCREW SYSTEM
K Number: K053394
·
Decision Dec 14, 2005
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
1040
Applicant Total
16
Review Days
8
Basic Information
- Device Name
- NEXA BONE SCREW SYSTEM
- K Number
- K053394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NEXA ORTHOPEDICS, INC.
- Date Received
- December 6, 2005
- Decision Date
- December 14, 2005
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by NEXA ORTHOPEDICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K072710 | NEXFIX COMPRESSION PIN | Nov 8, 2007 | Substantially Equivalent |
| K071147 | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM | Jul 20, 2007 | Substantially Equivalent |
| 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 |
| 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 |
| K032902 | SUBTALAR ARTHRORISIS IMPLANT | Dec 15, 2003 | Substantially Equivalent |