SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K082821
Substantially EquivalentSpine Smith Partners L.P.
FDA 510(k) clearance K082821 for SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2008-10-31. Applicant: Spine Smith Partners L.P..
Clearance details
- Applicant
- Spine Smith Partners L.P.
- Product code
- Code KWQ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.