FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED TRAM
K Number: K963394
·
Decision Nov 14, 1996
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
27
Review Days
78
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Basic Information
- Device Name
- OSTEOMED TRAM
- K Number
- K963394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteomed Corp.
- Date Received
- August 28, 1996
- Decision Date
- November 14, 1996
- 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 Osteomed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K151021 | OsteoMed Cannulated Screw System | Jul 15, 2015 | Substantially Equivalent |
| K022277 | OSTEOMED CRANIAL FLAP FIXATION SYSTEM | Apr 1, 2003 | Substantially Equivalent |
| K022887 | INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Nov 26, 2002 | Substantially Equivalent |
| K022886 | METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM | Nov 25, 2002 | Substantially Equivalent |
| K023260 | 1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM | Oct 18, 2002 | Substantially Equivalent |
| K013618 | INTRAORAL MANDIBULAR DISTRACTION SYSTEM | Aug 14, 2002 | Substantially Equivalent |
| K021618 | OSA RIGID INTERNAL FIXATION SYSTEM | Aug 8, 2002 | Substantially Equivalent |
| K012486 | OSTEOMED BIORESORBABLE FIXATION SYSTEM | Jan 16, 2002 | Substantially Equivalent |
| K010964 | AUTO-DRIVE LAG SCREW SYSTEM | Jul 5, 2001 | Substantially Equivalent |
| K010783 | 2.0/2.4 CANNULATED SCREW SYSTEM | May 30, 2001 | Substantially Equivalent |