SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X— 510(k) K060513
Substantially EquivalentSintea Biotech, Inc.
FDA 510(k) clearance K060513 for SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X, Substantially Equivalent on 2006-03-10. Applicant: Sintea Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Sintea Biotech, Inc.
- Product code
- Code KWP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami Beach, FL, US
Recent devices under product code KWP
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view all- K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
- K081631 — SINTEA BIOTECH PLS MULTI-AXIAL SCREWS
- K072198 — X-VOID, SPIDER
- K070181 — SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX
- K043355 — SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.