CONMED LINVATEC OSPREY DRILL SYSTEM— 510(k) K080444
Substantially EquivalentConmed Linvatec
FDA 510(k) clearance K080444 for CONMED LINVATEC OSPREY DRILL SYSTEM, Substantially Equivalent on 2008-04-02. Applicant: Conmed Linvatec. Device class: 2.
Clearance details
- Applicant
- Conmed Linvatec
- Product code
- Code HBC
- Device class
- Class 2
- Regulation
- 21 CFR 882.4360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, US
Recent devices under product code HBC
view allMore clearances from Conmed Linvatec
view all- K111779 — Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
- K102410 — MATRYX INTERFERENCE SCREW (5.0-6.5MM)
- K102339 — CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE
- K101100 — CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503
- K092898 — CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES
Adverse events under product code HBC
product code HBC- Malfunction
- 4,715
- Total
- 4,715
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.