FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THREADED FIXATION PIN
K Number: K963433
·
Decision Nov 6, 1996
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
11
Review Days
68
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Basic Information
- Device Name
- THREADED FIXATION PIN
- K Number
- K963433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthopaedic Biosystems, Ltd.
- Date Received
- August 30, 1996
- Decision Date
- November 6, 1996
- Product Code
- JDW
- 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 |
|---|---|---|---|
| JDW | Pin, Fixation, Threaded | FDA class 2 | Orthopedic |
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Other Clearances by Orthopaedic Biosystems, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K000797 | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 | Apr 3, 2000 | Substantially Equivalent |
| K982996 | POLYMER OBL SB ANCHOR / SUTURE COMBINATION | Mar 4, 1999 | Substantially Equivalent |
| K983169 | POLYMER THREADED ANCHOR | Dec 16, 1998 | Substantially Equivalent |
| K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION | Nov 20, 1998 | Substantially Equivalent |
| K972326 | PEBA ANCHOR/SUTURE COMBINATION | Feb 6, 1998 | Substantially Equivalent |
| K963420 | CANCELLOUS SCREW WASHER | Nov 15, 1996 | Substantially Equivalent |
| K963432 | GUIDE WIRES FOR CANNULATED SCREWS | Nov 13, 1996 | Substantially Equivalent |
| K962779 | COMPRESSION SCREW | Aug 23, 1996 | Substantially Equivalent for Some Indications |
| K951451 | PEBA ANCHOR (MULTIPLE SIZES) | Oct 31, 1995 | Substantially Equivalent for Some Indications |
| K942889 | SB ANCHOR | Aug 25, 1995 | Substantially Equivalent |