FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED BIORESORBABLE FIXATION SYSTEM
K Number: K012486
·
Decision Jan 16, 2002
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
27
Review Days
167
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
- OSTEOMED BIORESORBABLE FIXATION SYSTEM
- K Number
- K012486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed Corp.
- Date Received
- August 2, 2001
- Decision Date
- January 16, 2002
- Product Code
- DZL
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZL), ordered by most recent decision date.
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
FDA 510(k)
FDA Class 2
·Dental
Bone Screw
FDA 510(k)
FDA Class 2
·Dental
USTOMED Bone Fixation/Bone Augmentation Systems - PIN
FDA 510(k)
FDA Class 2
·Dental
GBR System
FDA 510(k)
FDA Class 2
·Dental
MP Pin flat without thread (36BMP000020/MP20)
FDA 510(k)
FDA Class 2
·Dental
KLS Martin Drill-Free MMF Screw
FDA 510(k)
FDA Class 2
·Dental
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 |
| K010964 | AUTO-DRIVE LAG SCREW SYSTEM | Jul 5, 2001 | Substantially Equivalent |
| K010783 | 2.0/2.4 CANNULATED SCREW SYSTEM | May 30, 2001 | Substantially Equivalent |
| K990944 | OSTEOMED INTRAORAL DISTRACTION SYSTEM | Jun 16, 1999 | Substantially Equivalent |