NORMED MINI EXTERNAL FIXATOR SYSTEM— 510(k) K022230
Substantially EquivalentOsteomedics, Inc.
FDA 510(k) clearance K022230 for NORMED MINI EXTERNAL FIXATOR SYSTEM, Substantially Equivalent on 2002-09-10. Applicant: Osteomedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Osteomedics, Inc.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Paramus, NJ, US
Recent devices under product code HRS
view allMore clearances from Osteomedics, Inc.
view all- K022035 — OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
- K022324 — NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
- K022231 — NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
- K022323 — NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
- K022325 — NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.