SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT— 510(k) K082795
Substantially EquivalentInterventional Spine, Inc.
FDA 510(k) clearance K082795 for SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT, Substantially Equivalent on 2008-12-12. Applicant: Interventional Spine, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Interventional Spine, Inc.
- Product code
- Code MRW
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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