FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONMED LINVATEC OSPREY DRILL SYSTEM
K Number: K080444
·
Decision Apr 2, 2008
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
25
Applicant Total
21
Review Days
43
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CONMED LINVATEC OSPREY DRILL SYSTEM
- K Number
- K080444
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4360
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conmed Linvatec
- Date Received
- February 19, 2008
- Decision Date
- April 2, 2008
- Product Code
- HBC
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBC | Motor, Drill, Electric | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBC), ordered by most recent decision date.
Traus SSG10 Surgical System
FDA 510(k)
FDA Class 2
·Neurology
Traus SSG30 Surgical System
FDA 510(k)
FDA Class 2
·Neurology
ORiGO System
FDA 510(k)
FDA Class 2
·Neurology
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
FDA 510(k)
FDA Class 2
·Neurology
hekaDrill
FDA 510(k)
FDA Class 2
·Neurology
MR8 Drill System, Midas Rex MR8 ClearView Tools
FDA 510(k)
FDA Class 2
·Neurology
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 |
| K073481 | THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES | Jan 7, 2008 | Substantially Equivalent |