ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183
FDA 510(k) clearance K023777 · decided 2002-12-11
Clearance details
- K-number
- K023777
- Device name
- ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183
- Applicant
- Arthronet Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-12
- Decision date
- 2002-12-11
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.