DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS— 510(k) K060638
Substantially EquivalentZimmer Spine, Inc.
FDA 510(k) clearance K060638 for DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS, Substantially Equivalent on 2006-04-06. Applicant: Zimmer Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer Spine, Inc.
- Product code
- Code NQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
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Recalls naming K060638
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 K060638.
Data sourced from openFDA. This site is unofficial and independent of the FDA.