FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
K Number: K073481
·
Decision Jan 7, 2008
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
21
Review Days
27
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Basic Information
- Device Name
- THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
- K Number
- K073481
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conmed Linvatec
- Date Received
- December 11, 2007
- Decision Date
- January 7, 2008
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Conmed Linvatec
| K Number | Device Name | ||
|---|---|---|---|
| K111779 | Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 | Aug 8, 2011 | Substantially Equivalent |
| K102410 | MATRYX INTERFERENCE SCREW (5.0-6.5MM) | Dec 21, 2010 | Substantially Equivalent |
| K102339 | CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE | Nov 23, 2010 | Substantially Equivalent |
| K101100 | CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 | Aug 26, 2010 | Substantially Equivalent |
| K092898 | CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES | Oct 19, 2009 | Substantially Equivalent |
| K090560 | CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS | Jun 29, 2009 | Substantially Equivalent |
| K083161 | ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) | Mar 27, 2009 | Substantially Equivalent |
| K080531 | CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY | Sep 5, 2008 | Substantially Equivalent |
| K072291 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR | Jul 14, 2008 | Substantially Equivalent |
| K080444 | CONMED LINVATEC OSPREY DRILL SYSTEM | Apr 2, 2008 | Substantially Equivalent |