SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
FDA 510(k) clearance K984543 · decided 1999-03-01
Clearance details
- K-number
- K984543
- Device name
- SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25
- Applicant
- Syntec Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-21
- Decision date
- 1999-03-01
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Chang Hua, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.