FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUERRERO - BELL DISTRACTOR
K Number: K972166
·
Decision Aug 11, 1997
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
11
Review Days
63
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Basic Information
- Device Name
- GUERRERO - BELL DISTRACTOR
- K Number
- K972166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Leibinger, Inc.
- Date Received
- June 9, 1997
- Decision Date
- August 11, 1997
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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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 |
| 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 |
| K963739 | LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS | Jan 22, 1997 | Substantially Equivalent for Some Indications |
| K963740 | LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS | Oct 28, 1996 | Substantially Equivalent |
| K961120 | MARKER SYSTEM FOR STEREOTAXIC NAVIGATION | May 10, 1996 | Substantially Equivalent |