SYNTHES SYNEX SPACER SYSTEM
FDA 510(k) clearance K003836 · decided 2001-05-29
Clearance details
- K-number
- K003836
- Device name
- SYNTHES SYNEX SPACER SYSTEM
- Applicant
- Synthes
- Decision
- Substantially Equivalent
- Date received
- 2000-12-12
- Decision date
- 2001-05-29
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- MQP
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paoli, PA, US
- Third-party review
- No
- Expedited review
- No
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