FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYNVASIVE CERAMIC SUTTING BLOCK
K Number: K930573
·
Decision Apr 7, 1994
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
7
Applicant Total
10
Review Days
427
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Basic Information
- Device Name
- SYNVASIVE CERAMIC SUTTING BLOCK
- K Number
- K930573
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synvasive Technology, Inc.
- Date Received
- February 4, 1993
- Decision Date
- April 7, 1994
- Product Code
- LXI
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LXI | Guide, Drill, Ligament | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Synvasive Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | Mar 22, 2011 | Substantially Equivalent |
| 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 |
| K950009 | POWERGRIP(TM) COMPRESSION FIXATION DEVICE | Aug 18, 1995 | Substantially Equivalent |
| K934336 | SPINALPLANE | Mar 10, 1995 | Substantially Equivalent for Some Indications |
| K933933 | CEBOPLANE | Apr 15, 1994 | Substantially Equivalent |
| K932869 | ARTHROPLANE | Mar 25, 1994 | Substantially Equivalent |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | Jan 7, 1994 | Substantially Equivalent |