Atlas FDA

MERCURY SPINAL SYSTEM

FDA 510(k) clearance K071914 · decided 2007-10-12

Clearance details

K-number
K071914
Device name
MERCURY SPINAL SYSTEM
Applicant
Spinal Elements, Inc.
Decision
Substantially Equivalent
Date received
2007-07-11
Decision date
2007-10-12
Days to decision
93 days
Clearance type
Traditional
Product code
NKB
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Carlsbad, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, recall (Z-1597-2015)Spinal Elements, Inc2015-05-11
Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to pr recall (Z-1246-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to pr recall (Z-1247-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to pr recall (Z-1248-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to pr recall (Z-1249-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to pr recall (Z-1250-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to pr recall (Z-1251-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to pr recall (Z-1252-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to pr recall (Z-1253-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to pr recall (Z-1254-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to pr recall (Z-1255-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to pro recall (Z-1256-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to pro recall (Z-1257-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to pro recall (Z-1258-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to pro recall (Z-1259-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to pro recall (Z-1260-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to pro recall (Z-1261-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to pro recall (Z-1262-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to pr recall (Z-1263-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to pr recall (Z-1264-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to pr recall (Z-1265-2013)Spinal Elements, Inc2013-05-07
Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to pr recall (Z-1266-2013)Spinal Elements, Inc2013-05-07