SURGICAL SIMPLEX P WITH TOBRAMYCIN— 510(k) K014199
Substantially EquivalentHowmedica Osteonics Corp.
FDA 510(k) clearance K014199 for SURGICAL SIMPLEX P WITH TOBRAMYCIN, Substantially Equivalent on 2003-05-06. Applicant: Howmedica Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code LOD
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
Recent devices under product code LOD
view allMore clearances from Howmedica Osteonics Corp.
view all- K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
- K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
- K130895 — REUNION RSA SHOULDER SYSTEM
- K123604 — ABG III MONOLITHIC HIP STEM
- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
Adverse events under product code LOD
product code LOD- Death
- 44
- Injury
- 3,004
- Malfunction
- 895
- Other
- 4
- Total
- 3,947
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 →
Recalls naming K014199
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K014199.
Data sourced from openFDA. This site is unofficial and independent of the FDA.