FDA.report

DJO SURGICAL

Primary DI
00190446758792
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
425-91-004
Device description
Linear PLUS, Stem, Standard, Size 4
Published
2023-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Premarket Submissions

SubmissionSupplement
K223779000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223779000EMPOWR™ blade stemEncore Medical, LLC2023-02-13LPH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190446758792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446758792001904467587921904467587920190446758792

GMDN Terms

TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.

Sterilization Methods

Method

Regulatory Flags

DUNS number
154074504
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190446905998DJO SURGICAL800-05-2142026-03-03
00190446960515DJO SURGICALS-2019612026-02-17
00190446905950DJO SURGICAL800-05-2102026-02-11
00190446905974DJO SURGICAL800-05-2112026-02-11
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446906117DJO SURGICAL801-05-2122026-02-11
00190446924470DJO SURGICALS-2019282025-10-10
00190446946007DJO SURGICALS-2019562025-12-11
00190446893332DJO SURGICAL941-01-32B2025-12-04
00190446893349DJO SURGICAL941-01-36D2025-12-04
00190446893356DJO SURGICAL941-01-40F2025-12-04
00190446893363DJO SURGICAL941-01-44H2025-12-04
00190446893370DJO SURGICAL942-01-32B2025-12-04
00190446893387DJO SURGICAL942-01-36D2025-12-04
00190446893394DJO SURGICAL942-01-40F2025-12-04
00190446893400DJO SURGICAL942-01-44H2025-12-04
00190446893417DJO SURGICAL943-01-32B2025-12-04
00190446893424DJO SURGICAL943-01-36D2025-12-04
00190446893431DJO SURGICAL943-01-40F2025-12-04
00190446893448DJO SURGICAL943-01-44H2025-12-04

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10885862639622AcuMatchExactech, Inc.KWY2026-03-19
10885862661227N/AExactech, Inc.KWY2026-03-19
10885862661241N/AExactech, Inc.KWY2026-03-19
10885862661265N/AExactech, Inc.KWY2026-03-19
10885862663160AcuMatchExactech, Inc.KWY2026-03-19
00887868551635StageOne SelectBiomet Orthopedics, LLCKWY2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCKWY2026-03-17
04048844693374implaFit®implantcast GmbHKWY2026-03-17
04048844693459implaFit®implantcast GmbHKWY2026-03-17
04048844693466implaFit®implantcast GmbHKWY2026-03-17
04048844693497implaFit®implantcast GmbHKWY2026-03-17
04048844693534implaFit®implantcast GmbHKWY2026-03-17
04048844693541implaFit®implantcast GmbHKWY2026-03-17
00889024706088Z1 STARTER BROACH, HYBRIDZimmer, Inc.KWY2026-02-23
00889024706095Z1 BROACH SZ 0, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706101Z1 BROACH SZ 1, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706118Z1 BROACH SZ 2, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706125Z1 BROACH SZ 3, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706132Z1 BROACH SZ 4, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706149Z1 BROACH SZ 5, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706156Z1 BROACH SZ 6, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706163Z1 BROACH SZ 7, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706170Z1 BROACH SZ 8, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706187Z1 BROACH SZ 9, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706194Z1 BROACH SZ 10, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706200Z1 BROACH SZ 11, HYBRID Zimmer, Inc.KWY2026-02-23