Atlas FDA

ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL

FDA 510(k) clearance K021008 · decided 2002-06-20

Clearance details

K-number
K021008
Device name
ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL
Applicant
Advanced Orthopaedic Solutions, Inc.
Decision
Substantially Equivalent
Date received
2002-03-28
Decision date
2002-06-20
Days to decision
84 days
Clearance type
Traditional
Product code
HSB
Device class
2
Regulation number
888.3020
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
San Pedro, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AOS Trochanteric Nail, 13mm x 20cm x 130, Product Part Number: 1037-200. recall (Z-118-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 9mm x 17cm x 130, Product Part Number: 1034-170. recall (Z-1181-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 9mm x 20cm x 130, Product Part Number: 1034-200. recall (Z-1182-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 11mm x 17cm x 130, Product Part Number: 1036-170. recall (Z-1183-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 11mm x 20cm x 130, Product Part Number: 1036-200. recall (Z-1184-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 11mm x 20cm x 135, Product Part Number: 1038-200. recall (Z-1186-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 10mm x 17cm x 130, Product Part Number: 1040-170 recall (Z-1187-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 10mm x 20cm x 130, Product Part Number: 1040-200. recall (Z-1188-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 12mm x 17cm x 130, Product Part Number: 1041-170. recall (Z-1189-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200. recall (Z-1190-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 10mm x 20cm x 135, Product Part Number: 1042-200. recall (Z-1191-2010)Advanced Orthopaedic Solutions Inc2010-03-22
AOS Trochanteric Nail, 12mm x 20cm x 135, Product Part Number: 1043-200. recall (Z-1192-2010)Advanced Orthopaedic Solutions Inc2010-03-22