HEALOS II BONE GRAFT SUBSTITUTE— 510(k) K081432
Substantially EquivalentDepuy Spine, Inc.
FDA 510(k) clearance K081432 for HEALOS II BONE GRAFT SUBSTITUTE, Substantially Equivalent on 2008-08-29. Applicant: Depuy Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Depuy Spine, Inc.
- Product code
- Code LYC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
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