GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
FDA 510(k) clearance K111593 · decided 2011-11-18
Clearance details
- K-number
- K111593
- Device name
- GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
- Applicant
- Bm Korea Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-07
- Decision date
- 2011-11-18
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- NDN
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.