Atlas FDA

CONSTRUX Mini Ti Spacer System

FDA 510(k) clearance K203342 · decided 2021-03-18

Clearance details

K-number
K203342
Device name
CONSTRUX Mini Ti Spacer System
Applicant
Orthofix, Inc.
Decision
Substantially Equivalent
Date received
2020-11-13
Decision date
2021-03-18
Days to decision
125 days
Clearance type
Traditional
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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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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3d Cage Cervical (K253041)Fims Co., Ltd.2026-07-23
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HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES (K260340)HC Biologics, LLC2026-04-13
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Recalls involving this device

RecordFirmDate
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System recall (Z-0896-2026)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