FDA.reportPublic FDA data

ORION WEDGE

Primary DI
00841742142142
Brand
ORION WEDGE
Company
HNM TOTAL RECON LLC
Model
HTR-04-224208
Catalog number
HTR-04-224208
Device description
ORION Ti PEEK EVANS Wedge - 22x22x8mm
Published
2017-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PLFBone Wedge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLFBone WedgeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150394000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150394000Tyber Medical Wedge SystemTyber Medical, LLC2015-07-28PLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841742142142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841742142142008417421421428417421421420841742142142

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric osteotomy fusion cageA sterile device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of synthetic polymer [e.g., polyetheretherketone (PEEK)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080024940
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841742143774ORIONHTR-04-304812HTR-04-3048122020-11-18
00841742143781ORIONHTR-04-304914HTR-04-3049142020-11-18
00841742143798ORIONHTR-04-304116HTR-04-3041162020-11-18
00841742143804ORIONHTR-04-304218HTR-04-3042182020-11-18
00841742143811ORIONHTR-04-304320HTR-04-3043202020-11-18
00841742143828ORIONHTR-04-304422HTR-04-3044222020-11-18
00841742143835ORIONHTR-04-304524HTR-04-3045242020-11-18
00841742143842ORIONHTR-04-304626HTR-04-3046262020-11-18
00841742143859ORIONHTR-04-304728HTR-04-3047282020-11-18
00841742143866ORIONHTR-04-304830HTR-04-3048302020-11-18
00841742143873ORIONHTR-04-304932HTR-04-3049322020-11-18
00841742143880ORIONHTR-04-304134HTR-04-3041342020-11-18
00841742143897ORIONHTR-04-304236HTR-04-3042362020-11-18
00841742143903ORIONHTR-04-304338HTR-04-3043382020-11-18
00841742143910ORIONHTR-04-304440HTR-04-3044402020-11-18
00841742143927ORIONHTR-04-404514HTR-04-4045142020-11-18
00841742143934ORIONHTR-04-404616HTR-04-4046162020-11-18
00841742143941ORIONHTR-04-404718HTR-04-4047182020-11-18
00841742143958ORIONHTR-04-404820HTR-04-4048202020-11-18
00841742143965ORIONHTR-04-404922HTR-04-4049222020-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G817103151100SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817103151200SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S101181806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S111121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
00810199190006ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190013ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190020ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24