FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS
K Number: K093078
·
Decision Jun 23, 2010
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
12
Review Days
266
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
- UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS
- K Number
- K093078
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bonutti Research, Inc.
- Date Received
- September 30, 2009
- Decision Date
- June 23, 2010
- 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 Bonutti Research, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | Nov 10, 2016 | Substantially Equivalent |
| K090175 | UNITY BETA PLLA SYSTEM | Sep 10, 2009 | Substantially Equivalent |
| K082906 | UNITY BETA ANCHOR SYSTEM | Oct 30, 2008 | Substantially Equivalent |
| K062820 | UNITY ALPHA SYSTEM | Mar 15, 2007 | Substantially Equivalent |
| K060283 | TRANSET SYSTEM | Feb 22, 2006 | Substantially Equivalent |
| K052799 | MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM | Dec 16, 2005 | Substantially Equivalent |
| K033717 | TRANSET FRACTURE FIXATION SYSTEM | Feb 25, 2004 | Substantially Equivalent |
| K013177 | MULTITAK SUTURE SNAP SYSTEM | Dec 19, 2001 | Substantially Equivalent |
| K012465 | MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR | Oct 29, 2001 | Substantially Equivalent |
| K010479 | MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR | May 8, 2001 | Substantially Equivalent |