FDA.reportPublic FDA data

AlloWedge

Primary DI
00191083047393
Brand
AlloWedge
Company
Rti Surgical, Inc.
Model
55-DISTRACTOR
Catalog number
55-DISTRACTOR
Device description
Distractor, Foot and Ankle Wedge
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
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083047393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083047393001910830473931910830473930191083047393

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, externalA hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). 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

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Primary DI, Brand, Company table
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00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
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M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
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M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
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