FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
K Number: K040990
·
Decision May 13, 2004
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
109
Applicant Total
56
Review Days
27
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
- MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
- K Number
- K040990
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Walter Lorenz Surgical, Inc.
- Date Received
- April 16, 2004
- Decision Date
- May 13, 2004
- Product Code
- NEU
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEU), ordered by most recent decision date.
HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOLLI 2 System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCOUT MD Surgical Guidance System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VizMark Preloaded Tissue Marker Device (VM-0001)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MammoSTAR Biopsy Site Identifier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UltraCor Twirl Breast Tissue Marker
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Walter Lorenz Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | Feb 9, 2007 | Substantially Equivalent |
| K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | Jan 12, 2007 | Substantially Equivalent |
| K063506 | LORENZ STERNAL CLOSURE SYSTEM | Dec 18, 2006 | Substantially Equivalent |
| K062842 | TWIST DRILL | Dec 4, 2006 | Substantially Equivalent |
| K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM | Jun 6, 2006 | Substantially Equivalent |
| K042516 | OTOMIMIX | Nov 8, 2004 | Substantially Equivalent |
| K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | May 14, 2004 | Substantially Equivalent |
| K040983 | LORENZ SELF-DRILLING IMF SCREW | May 5, 2004 | Substantially Equivalent |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | Dec 15, 2003 | Substantially Equivalent |
| K032228 | LORENZ 2.4 SELF DRILLING SCREWS | Aug 11, 2003 | Substantially Equivalent |