FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE
K Number: K896310
·
Decision Nov 20, 1989
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
19
Applicant Total
78
Review Days
19
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Basic Information
- Device Name
- ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE
- K Number
- K896310
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4930
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Acufex Microsurgical, Inc.
- Date Received
- November 1, 1989
- Decision Date
- November 20, 1989
- Product Code
- KGS
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGS | Retention Device, Suture | FDA class 1 | General, Plastic Surgery |
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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 |