Atlas FDA

Trigon PEEK HA Wedges

FDA 510(k) clearance K243231 · decided 2024-11-08

Clearance details

K-number
K243231
Device name
Trigon PEEK HA Wedges
Applicant
Nvision Biomedical Technologies
Decision
Substantially Equivalent
Date received
2024-10-09
Decision date
2024-11-08
Days to decision
30 days
Clearance type
Special
Product code
PLF
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
San Antonio, 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.

RecordFirmDate
ATLAS™ Expandable Osteotomy Wedge System (K252733)MiRus, LLC2026-02-19
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Auxano® Wedge Fixation System (K251791)Auxano Medical, LLC2025-09-25
OsteoSinter® EVANS and COTTON wedges and related accessories (K240461)Ames Medical Prosthetic Solutions, S.A.U.2024-12-06
Trigon Trigon HA Stand-Alone Wedge Fixation System (K234116)Nvision Biomedical Technologies2024-01-26
TITAN 3-D Wedge System (K231496)Paragon 28, Inc.2023-08-22
Trigon™ HA Stand-Alone Wedge Fixation System (K223226)Nvision Biomedical Technologies, Inc.2022-12-01
Trigon HA Wedge Fixation System (K220197)Nvision Biomedical Technologies, Inc.2022-02-23
Restor3d Utility Wedge (K201314)Restor3D, Inc.2021-06-17
Trigon HA Stand-Alone Wedge Fixation System (K203445)Nvision Biomedical Technologies, Inc.2020-12-21
Trigon HA Stand-Alone Wedge Fixation System (K193414)Nvision Biomedical Technologies, Inc.2020-02-25
Trigon™ Ti Stand-Alone Wedge Fixation System (K192645)Nvision Biomedical Technologies, Inc.2019-12-23

Recalls involving this device

No recalls on record reference this clearance.