FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ACROMED ILIAC SCREW
K Number: K884161
·
Decision May 3, 1989
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
111
Review Days
211
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Basic Information
- Device Name
- ACROMED ILIAC SCREW
- K Number
- K884161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Buckman Co., Inc.
- Date Received
- October 4, 1988
- Decision Date
- May 3, 1989
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K960451 | WEBB-MORLEY SPINE SYSTEM | Apr 18, 1996 | Substantially Equivalent for Some Indications |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent |
| K945756 | IMAGN(TM) 2000 SYSTEM | Dec 19, 1995 | Substantially Equivalent |
| K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT | Oct 19, 1995 | Substantially Equivalent |
| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent |
| K942751 | VANGUARD SERIES GAS REGULATORS | Feb 9, 1995 | Substantially Equivalent |