FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED CRANIAL FLAP FIXATION SYSTEM
K Number: K022277
·
Decision Apr 1, 2003
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
55
Applicant Total
27
Review Days
260
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Basic Information
- Device Name
- OSTEOMED CRANIAL FLAP FIXATION SYSTEM
- K Number
- K022277
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed Corp.
- Date Received
- July 15, 2002
- Decision Date
- April 1, 2003
- Product Code
- GXN
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | FDA class 2 | Neurology |
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Other Clearances by Osteomed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K151021 | OsteoMed Cannulated Screw System | Jul 15, 2015 | 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 |
| K990944 | OSTEOMED INTRAORAL DISTRACTION SYSTEM | Jun 16, 1999 | Substantially Equivalent |