FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMSET LOCKING PLATE SYSTEM
K Number: K905023
·
Decision Jan 31, 1992
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
10
Review Days
450
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Basic Information
- Device Name
- AMSET LOCKING PLATE SYSTEM
- K Number
- K905023
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Med/Surg, Inc.
- Date Received
- November 7, 1990
- Decision Date
- January 31, 1992
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by Advanced Med/Surg, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942108 | COHORT BONE BRUSH | Oct 11, 1994 | Substantially Equivalent |
| K931538 | AMSET(TM) CANNULATED BONE SCREW | May 4, 1994 | Substantially Equivalent for Some Indications |
| K921645 | AMSEN SPINE IMPACTOR INSTRUMENTS | Jun 3, 1992 | Substantially Equivalent |
| K921643 | AMSEN POSTERIOR DISC EVACUATOR | Jun 3, 1992 | Substantially Equivalent |
| K921642 | AMSEN DOUBLE-ENDED FORAMINAL PROBE | Jun 3, 1992 | Substantially Equivalent |
| K921644 | AMSEN HOCKEY STICK CHISEL | Jun 3, 1992 | Substantially Equivalent |
| K911768 | AMSET(TM) BONE SCREW | Oct 4, 1991 | Substantially Equivalent |
| K905014 | AMSET PLD SYSTEM | Apr 1, 1991 | Substantially Equivalent |
| K903808 | AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT | Jan 22, 1991 | Substantially Equivalent |