FDA.reportPublic FDA data

PHALINX

Primary DI
00840420166166
Brand
PHALINX
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
05-052
Catalog number
05-052
Published
2015-10-15
Public version status
Update
Distribution status
Not 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
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113006000I-FUSE HAMMER TOE SYSTEMSOrthopro, LLC2012-05-25HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420166166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420166166008404201661668404201661660840420166166

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00193982096274ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158620ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158675ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158729ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158774ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158828ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167615ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167660ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167714ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167769ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167813ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167868ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167912ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167967ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168018ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168063ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168117ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175740ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175795ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14