FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K Number: K012409
·
Decision Oct 18, 2001
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
14
Applicant Total
56
Review Days
80
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Basic Information
- Device Name
- LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
- K Number
- K012409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Walter Lorenz Surgical, Inc.
- Date Received
- July 30, 2001
- Decision Date
- October 18, 2001
- Product Code
- NHB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | FDA class 2 | Ear, Nose, Throat |
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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 |
| K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS | May 13, 2004 | Substantially Equivalent |
| K040983 | LORENZ SELF-DRILLING IMF SCREW | May 5, 2004 | Substantially Equivalent |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | Dec 15, 2003 | Substantially Equivalent |