FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
ACTIVASCREW
K Number: K072848
·
Decision Nov 2, 2007
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
9
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACTIVASCREW
- K Number
- K072848
- 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
- October 4, 2007
- Decision Date
- November 2, 2007
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWC), ordered by most recent decision date.
VEOFIX Snap Off Screw
FDA 510(k)
FDA Class 2
·Orthopedic
CoLink® & CoLag® Non-Sterile Screws
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Compression Screws
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Beaming System
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Threaded Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
TITAN Nail; APTUS K-Wire System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Bioretec, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| DEN220030 | RemeOs Screw LAG Solid | Mar 29, 2023 | Unknown |
| K133950 | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) | Jan 22, 2014 | Substantially Equivalent |
| 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 |
| 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 |