FDA.reportPublic FDA data

ORTHOLOC 3Di

Primary DI
00840420154613
Brand
ORTHOLOC 3Di
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
59235570
Catalog number
59235570
Device description
Plating System
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121425000ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEMWrightmedicaltechnologyinc2012-10-01HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420154613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420154613008404201546138404201546130840420154613

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length70Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797103695PROSTEP™ MICA™57790009577900092022-02-01
00889797103718PROSTEP™ MICA™57790011577900112022-02-01
00889797111089PROPHECY INCOMPASS33820300338203002026-06-23
00889797111096PROPHECY INCOMPASS33820302338203022026-06-23
00889797111102PROPHECY INCOMPASS33820303338203032026-06-23
00889797111119PROPHECY INCOMPASS33820304338203042026-06-23
00889797111126PROPHECY INCOMPASS33820305338203052026-06-23
00889797114820PROPHECY INCOMPASSPROPINCPROPINC2026-06-23
00889797114837PROPHECY INCOMPASSPROPINCFPROPINCF2026-06-23
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132452Tools - TWFTrimed, INC.HRS2026-08-18
00842188132230Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132247Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132254Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132261Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132445Tools - TWFTrimed, INC.HRS2026-08-17
00193982096274ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096274ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14