FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
LIGAFIX INTERFERENCE SCREW
K Number: K122228
·
Decision Oct 3, 2012
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
3
Review Days
69
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
- LIGAFIX INTERFERENCE SCREW
- K Number
- K122228
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sbm Sciences For Bio Materials
- Date Received
- July 26, 2012
- Decision Date
- October 3, 2012
- Product Code
- MAI
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAI), ordered by most recent decision date.
Arthrex Bioabsorbable PushLock Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
SF Push-in Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Biosteon® Screw
FDA 510(k)
FDA Class 2
·Orthopedic
BioBrace® Extra-Articular Ligament Augmentation Kit
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Interference Screw
FDA 510(k)
FDA Class 2
·Orthopedic