FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
K Number: K133950
·
Decision Jan 22, 2014
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
- K Number
- K133950
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioretec, Ltd.
- Date Received
- December 23, 2013
- Decision Date
- January 22, 2014
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by Bioretec, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| DEN220030 | RemeOs Screw LAG Solid | Mar 29, 2023 | Unknown |
| K130716 | BIORETEC ACTIVASCREW INTERFERENCE | Aug 28, 2013 | Substantially Equivalent |
| K080879 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM | Jun 24, 2008 | Substantially Equivalent |
| K081392 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN | Jun 18, 2008 | Substantially Equivalent |
| K072848 | ACTIVASCREW | Nov 2, 2007 | Substantially Equivalent |
| K071863 | ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) | Aug 31, 2007 | Substantially Equivalent |
| K062980 | ACTIVASCREW | Nov 22, 2006 | Substantially Equivalent |
| K061164 | ACTIVAPIN | Jul 6, 2006 | Substantially Equivalent |