FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K Number: K922766
·
Decision Jul 9, 1993
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
78
Review Days
402
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Basic Information
- Device Name
- ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
- K Number
- K922766
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Acufex Microsurgical, Inc.
- Date Received
- June 2, 1992
- Decision Date
- July 9, 1993
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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Other Clearances by Acufex Microsurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961555 | ACUFEX TAG BIOABSORBABLE ANCHORS | Jul 10, 1996 | Substantially Equivalent |
| K961853 | PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER | Jun 21, 1996 | Substantially Equivalent |
| K954246 | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW | Feb 15, 1996 | Substantially Equivalent for Some Indications |
| K952535 | ACUFEX ENDOBUTTON TAPE | Feb 8, 1996 | Substantially Equivalent for Some Indications |
| K953276 | ACUFEX TAG DELIVERY SYSTEM | Oct 5, 1995 | Substantially Equivalent |
| K953459 | ACUFEX TAG ANCHOR | Aug 23, 1995 | Substantially Equivalent |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Jun 30, 1995 | Substantially Equivalent |
| K944500 | ACUFEX PATELLAR BONE BLOCK SIZER | Jun 12, 1995 | Substantially Equivalent |
| K951859 | ACUFEX ENDOBUTTON PACK | Jun 9, 1995 | Substantially Equivalent |
| K946346 | ACUFEX TAG(R) BIOABSORBABLE ANCHORS | Apr 26, 1995 | Substantially Equivalent |