FDA.reportPublic FDA data

AlloWedge

Primary DI
00191083047355
Brand
AlloWedge
Company
Rti Surgical, Inc.
Model
55-E-22-22-8
Catalog number
55-E-22-22-8
Device description
EVANS TRIAL ASSEMBLY, 8mm
Published
2024-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHXTrousers, anti-shock

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHXTrousers, Anti-ShockCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083047355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083047355001910830473551910830473550191083047355

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com

Regulatory Flags#

DUNS number
117560455
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191083045092RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2ccZR0302001510Z2024-05-27
00191083045108RegenaVate™ Formable DBM RT, 1ccZR0201005301Z2024-05-27
00191083045078RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5ccZR0305001504Z2024-05-27
00191083045085RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1ccZR0301001505Z2024-05-27
00191083045115RegenaVate™ Formable DBM RT, 2ccZR0202005302Z2024-05-27
10885862093196OPTEFORM® Allograft Full Disc, 3 x 20mm, 1cc002523600-03-202015-11-06
10885862093202OPTEFORM® Allograft Disc, 30mm x 3mm, 2cc002530600-03-302015-11-06
10885862093219OPTEFORM® Allograft Disc, 45mm x 5mm, 8cc002545600-05-452015-11-06
10885862093226OPTEFORM® Allograft Full Disc, 5 x 90mm, 32cc002529600-05-902015-11-06
10885862094094OPTEFORM® Allograft Partial Disc, 75mm x 5mm, 15cc002575602-05-752015-11-06
10885862094100OPTEFORM® Allograft Partial Disc, 90mm x 5mm, 22cc002590602-05-902015-11-06
10885862094223OPTEFORM® Allograft Paste, 2cc005102606-01-022015-11-06
10885862094230OPTEFORM® Allograft Paste, 5cc005105606-01-052015-11-06
10885862094247OPTEFORM® Allograft Paste, 10cc005110606-01-102015-11-06
10885862094254OPTEFORM® Allograft Paste, 20cc005120606-01-202015-11-06
10885862094384OPTEFIL® Allograft Paste, 1cc005001616-01-012015-11-06
10885862094391OPTEFIL® Allograft Paste, 5cc005005616-01-052015-11-06
10885862094407OPTEFIL® Allograft Paste, 10cc005010616-01-102015-11-06
10885862094599Synergent™ DBM, 1cc004901630-00-012015-11-06
10885862094605Synergent™ DBM, 5cc004905630-00-052015-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089589ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00198506089596ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00885556919620R3Smith & Nephew, Inc.LHX2024-11-06
00885556919613R3Smith & Nephew, Inc.LHX2024-11-04
00191083047300AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047317AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047324AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047331AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047348AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047362AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047379AlloWedgeRti Surgical, Inc.LHX2024-10-14
00840343722876GEN2SURGIX MEDICAL LLCLHX2024-06-28
08800017205267LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
08800068981486LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
00840343720537GEN2SURGIX MEDICAL LLCLHX2023-12-15
00840343720957GEN2SURGIX MEDICAL LLCLHX2023-12-15
10889981321390SpecialsSeaspine Orthopedics CorporationLHX2023-12-06
00840343719326Gen2SURGIX MEDICAL LLCLHX2023-11-14
00840343719364Gen2SURGIX MEDICAL LLCLHX2023-11-14
00885556910757LegionSmith & Nephew, Inc.LHX2023-09-06
00840019967655Reform® Ti CT Modular MIS Pedicle Screw SystemPRECISION SPINE, INC.LHX2023-08-07
00885556832417Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LHX2023-08-02
10889981308315SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308322SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308339SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308346SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308353SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308438SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
00850005827337GENESIS AWL/TAPPERGenesis Biologics, Inc.LHX2023-03-16
00885556850794Cadence Total Ankle SystemSmith & Nephew, Inc.LHX2023-02-02