FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K Number: K963739
·
Decision Jan 22, 1997
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
11
Review Days
127
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Basic Information
- Device Name
- LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
- K Number
- K963739
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Howmedica Leibinger, Inc.
- Date Received
- September 17, 1996
- Decision Date
- January 22, 1997
- 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 |
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Other Clearances by Howmedica Leibinger, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970912 | LEIBINGER SELF-DRILLING SCREW | Oct 1, 1997 | Substantially Equivalent |
| K972154 | COHEN DISTRACTOR | Aug 11, 1997 | Substantially Equivalent |
| K972166 | GUERRERO - BELL DISTRACTOR | Aug 11, 1997 | Substantially Equivalent |
| K961719 | EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES | Jul 17, 1997 | Substantially Equivalent |
| K963030 | LEIBINGER IMF SCREW | Apr 11, 1997 | Substantially Equivalent |
| K970911 | LEE PLATE | Apr 11, 1997 | Substantially Equivalent |
| K963741 | LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS | Feb 6, 1997 | Substantially Equivalent |
| K964649 | VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE | Jan 24, 1997 | Substantially Equivalent |
| K963740 | LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS | Oct 28, 1996 | Substantially Equivalent |
| K961120 | MARKER SYSTEM FOR STEREOTAXIC NAVIGATION | May 10, 1996 | Substantially Equivalent |