FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STABLELOC II EXTERNAL FIXATOR
K Number: K965029
·
Decision Feb 19, 1997
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
84
Applicant Total
43
Review Days
64
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Basic Information
- Device Name
- STABLELOC II EXTERNAL FIXATOR
- K Number
- K965029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acu Med, Inc.
- Date Received
- December 17, 1996
- Decision Date
- February 19, 1997
- Product Code
- JEC
- 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 |
|---|---|---|---|
| JEC | Component, Traction, Invasive | FDA class 2 | Orthopedic |
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Other Clearances by Acu Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021321 | WRIST FUSION PLATE | Jul 17, 2002 | Substantially Equivalent |
| K013616 | POLARUS CAP SCREW | Dec 19, 2001 | Substantially Equivalent |
| K012655 | CONGRUENT BONE PLATE SYSTEM | Nov 7, 2001 | Substantially Equivalent |
| K992525 | ACUMED MODULAR SHOULDER SYSTEM | Feb 4, 2000 | Substantially Equivalent |
| K993657 | ACUMED SUTURE ANCHOR | Jan 13, 2000 | Substantially Equivalent |
| K980103 | ACUMED SUTURE ANCHOR | Mar 16, 1998 | Substantially Equivalent |
| K965028 | ACUMED SUTURE WASHER | Mar 17, 1997 | Substantially Equivalent |
| K964500 | ACUMED TENSION BAND PIN | Dec 9, 1996 | Substantially Equivalent |
| K963026 | TBD | Oct 28, 1996 | Substantially Equivalent |
| K963118 | EXTREMITY BONE SCREW | Oct 10, 1996 | Substantially Equivalent for Some Indications |