FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
K Number: K132733
·
Decision Jan 3, 2014
Classifications
1
FEI Numbers
272
Registration Numbers
272
Same Product Code
92
Applicant Total
25
Review Days
122
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Basic Information
- Device Name
- ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
- K Number
- K132733
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthohelix Surgical Designs, Inc.
- Date Received
- September 3, 2013
- Decision Date
- January 3, 2014
- Product Code
- HTN
- 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 |
|---|---|---|---|
| HTN | Washer, Bolt Nut | FDA class 2 | Orthopedic |
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Other Clearances by Orthohelix Surgical Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K141004 | INTRAOSSEOUS FIXATION SYSTEM | Aug 21, 2014 | Substantially Equivalent |
| K142148 | ORTHOHELIX STAPLE SYSTEM | Aug 21, 2014 | Substantially Equivalent |
| K141301 | MAXLOCK EXTREME ELBOW FRACTURE SYSTEM | Jul 11, 2014 | Substantially Equivalent |
| K132591 | MAXLOCK EXTREME SYSTEM | Sep 17, 2013 | Substantially Equivalent |
| K130832 | ORTHOHELIX STAPLE SYSTEM | Aug 15, 2013 | Substantially Equivalent |
| K131324 | MAXTORQUE SCREW SYSTEM | May 31, 2013 | Substantially Equivalent |
| K123203 | MAXLOCK EXTREME SYSTEM MODEL MXL | Dec 14, 2012 | Substantially Equivalent |
| K122005 | MAXLOCK EXTREME SYSTEM | Sep 6, 2012 | Substantially Equivalent |
| K121437 | MINI MAXLOCK EXTREME PLATING SYSTEM | Jun 13, 2012 | Substantially Equivalent |
| K120165 | INTRAOSSEOUS FIXATION SYSTEM | Apr 17, 2012 | Substantially Equivalent |