FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM
K Number: K951232
·
Decision Aug 25, 1995
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
14
Review Days
158
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
- EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM
- K Number
- K951232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Medical Electronics, Inc.
- Date Received
- March 20, 1995
- Decision Date
- August 25, 1995
- 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 American Medical Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952348 | OGDEN ANCHOR | Aug 21, 1995 | Substantially Equivalent |
| K950875 | OGDEN ANCHOR | Jul 11, 1995 | Substantially Equivalent |
| K951493 | OGDEN ANCHOR | Jul 3, 1995 | Substantially Equivalent |
| K951545 | OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS | Jul 3, 1995 | Substantially Equivalent |
| K941029 | OGDEN ANCHOR-SMALL (TENTATIVE) | Feb 9, 1995 | Substantially Equivalent |
| K931381 | AME UNIVERSAL FIXATION SYSTEM | Feb 1, 1995 | Substantially Equivalent for Some Indications |
| K935065 | OGDEN ANCHOR ADDITIONAL APPLICATIONS | Jan 30, 1995 | Substantially Equivalent |
| K942300 | SILKON TITANIUM CABLE SYSTEM | Jan 9, 1995 | Unknown |
| K935167 | OGDEN ANCHOR (MODIFICATION) | Jul 12, 1994 | Substantially Equivalent for Some Indications |
| K932687 | AME(R) UNIVERSIAL CABLE SYSTEM | May 3, 1994 | Substantially Equivalent |