SYNTHES CONTOURED SYNMESH SPACER— 510(k) K041389
Substantially EquivalentSynthes Spine
FDA 510(k) clearance K041389 for SYNTHES CONTOURED SYNMESH SPACER, Substantially Equivalent on 2004-10-01. Applicant: Synthes Spine. Device class: 2.
Clearance details
- Applicant
- Synthes Spine
- Product code
- Code MQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Chester, PA, US
Recent devices under product code MQP
view allMore clearances from Synthes Spine
view allAdverse events under product code MQP
product code MQP- Injury
- 372
- Malfunction
- 519
- Total
- 891
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 K041389
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 K041389.
Data sourced from openFDA. This site is unofficial and independent of the FDA.