FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OGDEN ANCHOR-SMALL (TENTATIVE)
K Number: K941029
·
Decision Feb 9, 1995
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
14
Review Days
339
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Basic Information
- Device Name
- OGDEN ANCHOR-SMALL (TENTATIVE)
- K Number
- K941029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Medical Electronics, Inc.
- Date Received
- March 7, 1994
- Decision Date
- February 9, 1995
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by American Medical Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951232 | EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM | Aug 25, 1995 | Substantially Equivalent |
| K952348 | OGDEN ANCHOR | Aug 21, 1995 | Substantially Equivalent |
| K950875 | OGDEN ANCHOR | Jul 11, 1995 | Substantially Equivalent |
| K951493 | OGDEN ANCHOR | Jul 3, 1995 | Substantially Equivalent |
| K951545 | OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS | Jul 3, 1995 | Substantially Equivalent |
| K931381 | AME UNIVERSAL FIXATION SYSTEM | Feb 1, 1995 | Substantially Equivalent for Some Indications |
| K935065 | OGDEN ANCHOR ADDITIONAL APPLICATIONS | Jan 30, 1995 | Substantially Equivalent |
| K942300 | SILKON TITANIUM CABLE SYSTEM | Jan 9, 1995 | Unknown |
| K935167 | OGDEN ANCHOR (MODIFICATION) | Jul 12, 1994 | Substantially Equivalent for Some Indications |
| K932687 | AME(R) UNIVERSIAL CABLE SYSTEM | May 3, 1994 | Substantially Equivalent |