FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICRAFT SCREW FIXATION SYSTEM
K Number: K080447
·
Decision Jun 13, 2008
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
10
Review Days
115
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
- SURGICRAFT SCREW FIXATION SYSTEM
- K Number
- K080447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgicraft , Ltd.
- Date Received
- February 19, 2008
- Decision Date
- June 13, 2008
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBI), ordered by most recent decision date.
Dione PEEK Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Y-Knotless Flex Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
Anchor with Fiber Wire and Disposable Inserter
FDA 510(k)
FDA Class 2
·Orthopedic
ArthroTAK Tendon Anchor Kit
FDA 510(k)
FDA Class 2
·Orthopedic
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTak Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Surgicraft , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K091207 | SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE | Feb 15, 2011 | Substantially Equivalent |
| K072370 | SURGICRAFT SURGICAL MESH SYSTEM | Jul 24, 2008 | Substantially Equivalent |
| K073109 | STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM | Jun 4, 2008 | Substantially Equivalent |
| K072415 | STALIF (TM) C | Jan 25, 2008 | Substantially Equivalent |
| K051027 | STALIF TT | Jun 29, 2005 | Substantially Equivalent |
| K041617 | STALIF TT | Sep 8, 2004 | Substantially Equivalent |
| K991662 | TITANIUM HARTSHILL SYSTEM | Nov 8, 1999 | Substantially Equivalent |
| K982719 | THE BONE TIE | Sep 25, 1998 | Substantially Equivalent |
| K965221 | RANSFORD CERVICAL FIXATION SYSTEM | Aug 7, 1997 | Substantially Equivalent |