FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
SMARTSCREW
K Number: K012001
·
Decision Jul 18, 2001
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
12
Review Days
21
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
- SMARTSCREW
- K Number
- K012001
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionx Implants, Ltd.
- Date Received
- June 27, 2001
- Decision Date
- July 18, 2001
- 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 Bionx Implants, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K030388 | IMPACT SUTURE ANCHOR. MODEL 433510 | Apr 24, 2003 | Substantially Equivalent |
| K020056 | DUET SUTURE ANCHOR | Jun 26, 2002 | Substantially Equivalent |
| K012000 | 1.5MM BONE FIXATION KIT | Jul 18, 2001 | Substantially Equivalent |
| K003077 | SMARTSCREW MODEL 222006...227510 | Apr 26, 2001 | Substantially Equivalent |
| K003757 | THERMOFX MESH | Feb 7, 2001 | Substantially Equivalent |
| K000616 | SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 | Mar 23, 2000 | Substantially Equivalent |
| K993074 | SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 | Dec 10, 1999 | Substantially Equivalent |
| K993073 | SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 | Dec 6, 1999 | Substantially Equivalent |
| K993453 | MENISCUS ARROW, MODELS 531110, 531113, 531116 | Nov 9, 1999 | Substantially Equivalent |
| K992947 | CANNULATED SMARTSCREW MODELS 224540C, 224570C | Sep 21, 1999 | Substantially Equivalent |