FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWERGRIP(TM) COMPRESSION FIXATION DEVICE
K Number: K950009
·
Decision Aug 18, 1995
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
93
Applicant Total
10
Review Days
227
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Basic Information
- Device Name
- POWERGRIP(TM) COMPRESSION FIXATION DEVICE
- K Number
- K950009
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Synvasive Technology, Inc.
- Date Received
- January 3, 1995
- Decision Date
- August 18, 1995
- Product Code
- JDW
- 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 |
|---|---|---|---|
| JDW | Pin, Fixation, Threaded | FDA class 2 | Orthopedic |
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Other Clearances by Synvasive Technology, Inc.
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|---|---|---|---|
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| K070108 | ELIBRA DYNAMIC KNEE BALANCER | Apr 4, 2007 | Substantially Equivalent |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | Aug 26, 1997 | Substantially Equivalent |
| K961522 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN | Sep 23, 1996 | Substantially Equivalent |
| K934336 | SPINALPLANE | Mar 10, 1995 | Substantially Equivalent for Some Indications |
| K933933 | CEBOPLANE | Apr 15, 1994 | Substantially Equivalent |
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | Apr 7, 1994 | Substantially Equivalent |
| K932869 | ARTHROPLANE | Mar 25, 1994 | Substantially Equivalent |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | Jan 7, 1994 | Substantially Equivalent |