SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
FDA 510(k) clearance K040939 · decided 2004-05-12
Clearance details
- K-number
- K040939
- Device name
- SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
- Applicant
- Disc-O-Tech Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-12
- Decision date
- 2004-05-12
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Herzliya, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Disc-O-Tech Medical Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.