FDA.reportPublic FDA data

EVOS

Primary DI
00885556907474
Brand
EVOS
Company
Smith & Nephew, Inc.
Model
70275308
Catalog number
70275308
Device description
EVOS PELVIC 3.5MM POSTERIOR WALL TABBED PLATE STANDARD 8 HOLE, RIGHT
Published
2025-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241666000EVOS Pelvic and Acetabular SystemSmith & Nephew2025-02-19HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556907474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556907474008855569074748855569074740885556907474

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986482600CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482617CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482624CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482631CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482648CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482655CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482662CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482679CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482686CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482792CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482808CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482877CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482884CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482891CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482907CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482914CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482921CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482952CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482969CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482976CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482983CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482990CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483027CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483034CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986483041CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-26
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
00810112599275TriLEAPSynthes GmbHHRS2025-03-20
00810112599169TriLEAPSynthes GmbHHRS2025-03-18