HARMONY PORT SYSTEM, MODEL 1907 SERIES— 510(k) K050706
Substantially EquivalentSpinal Concepts, Inc.
FDA 510(k) clearance K050706 for HARMONY PORT SYSTEM, MODEL 1907 SERIES, Substantially Equivalent on 2005-04-15. Applicant: Spinal Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Spinal Concepts, Inc.
- Product code
- Code GZT
- Device class
- Class 2
- Regulation
- 21 CFR 882.4800
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
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More clearances from Spinal Concepts, Inc.
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