FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A.M. Surgical Intramedullary Fixation Device
K Number: K180087
·
Decision May 18, 2018
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
6
Review Days
126
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Basic Information
- Device Name
- A.M. Surgical Intramedullary Fixation Device
- K Number
- K180087
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A.M. Surgical, Inc.
- Date Received
- January 12, 2018
- Decision Date
- May 18, 2018
- 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 A.M. Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K191771 | SECURE Screw | Oct 16, 2019 | Substantially Equivalent |
| K191345 | Pegasus System | Jul 17, 2019 | Substantially Equivalent |
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | Mar 13, 2008 | Substantially Equivalent |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | Oct 7, 2004 | Substantially Equivalent |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | Dec 30, 1998 | Substantially Equivalent |