FDA.reportPublic FDA data

eZ-Fix

Primary DI
00841132142325
Brand
eZ-Fix
Company
ORTHOPEDIATRICS CORP.
Model
500-G
Catalog number
500-G
Device description
Drill guide, Half Pin
Published
2020-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052196000VILEX X-FIXVilex, Inc.2005-11-22KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132142325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132142325008411321423258411321423250841132142325

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379bsmith@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008405368002063P Hip System01-3002-102501-3002-10252026-06-12
008405368002133P Hip System01-3002-202501-3002-20252026-06-12
008405368002203P Hip System01-3002-302501-3002-30252026-06-12
00840536822864Response Spine01-1600-001701-1600-00172026-08-21
00840536822871Response Spine01-1300-011201-1300-01122026-08-21
00840536822888Response Spine01-1300-011301-1300-01132026-08-21
00840536822895Response Spine01-1300-611501-1300-61152026-08-21
00840536822901Response Spine01-1300-611601-1300-61162026-08-21
00840536824707Response Spine01-1600-607301-1600-60732026-08-21
00840536824974PedFlex Flexible Nailing System00-1001-1015-S00-1001-1015-S2026-08-14
00840536824981PedFlex Flexible Nailing System00-1001-1020-S00-1001-1020-S2026-08-14
00840536824998PedFlex Flexible Nailing System00-1001-1025-S00-1001-1025-S2026-08-14
00840536825001PedFlex Flexible Nailing System00-1001-1030-S00-1001-1030-S2026-08-14
00840536825018PedFlex Flexible Nailing System00-1001-1035-S00-1001-1035-S2026-08-14
00840536825025PedFlex Flexible Nailing System00-1001-1040-S00-1001-1040-S2026-08-14
00840536825032PedFlex Flexible Nailing System00-1001-1115-S00-1001-1115-S2026-08-14
00840536825049PedFlex Flexible Nailing System00-1001-1120-S00-1001-1120-S2026-08-14
00840536825056PedFlex Flexible Nailing System00-1001-1125-S00-1001-1125-S2026-08-14
00840536825063PedFlex Flexible Nailing System00-1001-1130-S00-1001-1130-S2026-08-14
00840536825070PedFlex Flexible Nailing System00-1001-1135-S00-1001-1135-S2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
00841132142905eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142950eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132143025eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
07613327079241HOFFMANNStryker GmbHKTT2018-09-24
07613327079272HOFFMANNStryker GmbHKTT2018-09-24
07613327079333HOFFMANNStryker GmbHKTT2018-09-24
07613327079395HOFFMANNStryker GmbHKTT2018-09-24
07613327079401HOFFMANNStryker GmbHKTT2018-09-24
07613327079449HOFFMANNStryker GmbHKTT2018-09-24
07613327079470HOFFMANNStryker GmbHKTT2018-09-24
07613327079500HOFFMANNStryker GmbHKTT2018-09-24
07613327079517HOFFMANNStryker GmbHKTT2018-09-24