Atlas FDA

CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System

FDA 510(k) clearance K172437 · decided 2017-11-02

Clearance details

K-number
K172437
Device name
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
Applicant
Orthofix, Inc.
Decision
Substantially Equivalent
Date received
2017-08-11
Decision date
2017-11-02
Days to decision
83 days
Clearance type
Special
Product code
ODP
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Lewisville, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer Syste recall (Z-0891-2026)Orthofix U.S. LLC2025-12-11
Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog recall (Z-0892-2026)Orthofix U.S. LLC2025-12-11
Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/ recall (Z-0893-2026)Orthofix U.S. LLC2025-12-11

PMA approvals by this applicant

RecordFirmDate
CervicalStim® (P030034/S017)Orthofix, Inc.2022-06-14
PhysioStim®, SpinalStim® (P850007/S046)Orthofix, Inc.2022-06-14
SpinalStim (P850007/S044)Orthofix, Inc.2020-03-27
CervicalStim (P030034/S015)Orthofix, Inc.2019-10-08
PhysioStim and SpinalStim (P850007/S043)Orthofix, Inc.2019-10-08
SpinalStim (P850007/S042)Orthofix, Inc.2019-07-03
PhysioStim and SpinalStim (P850007/S041)Orthofix, Inc.2019-06-18
CervicalStim (P030034/S014)Orthofix, Inc.2019-06-18