FDA.report

SALVATION

Primary DI
00889797057066
Brand
SALVATION
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
SEF805PK
Catalog number
SEF805PK
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications

CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889797057066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797057066008897970570668897970570660889797057066

GMDN Terms

TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags

DUNS number
807201207
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797023368INVISION600022012016-09-17
00889797023375INVISION600023002016-09-17
00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

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00888867543256Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543331Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543348Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543355Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543362Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543379Arthrex®ARTHREX, INC.KTT2026-03-13
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00888867543591Arthrex®ARTHREX, INC.KTT2026-03-13
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00888867543638Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543645Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543676Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543690Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543706Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543713Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543799Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543843Arthrex®ARTHREX, INC.KTT2026-03-13
00888867543881Arthrex®ARTHREX, INC.KTT2026-03-13
00841731149077DYNEX MICROVILEX LLCKTT2026-03-03
00889795151827The Brachiator Mini External Fixation SystemParagon 28, Inc.KTT2025-12-16
00889795151834The Brachiator Mini External Fixation SystemParagon 28, Inc.KTT2025-12-16
00889795151841The Brachiator Mini External Fixation SystemParagon 28, Inc.KTT2025-12-16
00889795151858The Brachiator Mini External Fixation SystemParagon 28, Inc.KTT2025-12-16