FDA.reportPublic FDA data

EVOS

Primary DI
00885556784020
Brand
EVOS
Company
Smith & Nephew, Inc.
Model
71177689N
Catalog number
71177689N
Device description
EVOS DOUBLE WASHER FOR 4.5MM SCREW
Published
2021-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDGWASHER, BOLT, NUT, NON-SPINAL, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDGWasher, Bolt, Nut, Non-Spinal, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201918000
K213126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201918000EVOS Large Fragment Plating SystemSmith & Nephew, Inc.2020-11-16HRS
K213126000Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.2022-09-29JDO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556784020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556784020008855567840208855567840200885556784020

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556863602Titan Reverse Shoulder SystemDGB-0960-08LRGDGB-0960-08LRG2022-12-21
00885556863633Titan Reverse Shoulder SystemDRL-0960-054-15DRL-0960-054-152022-12-21
00885556863640Titan Reverse Shoulder SystemDRL-0960-054-25DRL-0960-054-252022-12-21
00885556864876Universal2 Total Wrist Implant System2605202605202023-01-19
00885556864883Universal2 Total Wrist Implant System2605252605252023-01-19
00885556864890Universal2 Total Wrist Implant System2605302605302023-01-19
00885556864906Universal2 Total Wrist Implant System2605352605352023-01-19
00885556865071Universal2 Total Wrist Implant System2645152645152022-12-22
00885556865088Universal2 Total Wrist Implant System2645202645202023-01-19
00885556865095Universal2 Total Wrist Implant System2645252645252023-01-19
00885556865125Universal2 Total Wrist Implant System2651002651002023-01-19
00885556865149Universal2 Total Wrist Implant System2653002653002023-01-19
00885556865163Universal2 Total Wrist Implant System2661002661002023-01-19
00885556865170Universal2 Total Wrist Implant System2661012661012023-01-19
00885556865187Universal2 Total Wrist Implant System2661022661022023-01-19
00885556865194Universal2 Total Wrist Implant System2662002662002023-01-19
00885556865200Universal2 Total Wrist Implant System2662012662012023-01-19
00885556865217Universal2 Total Wrist Implant System2662022662022023-01-19
00885556865224Universal2 Total Wrist Implant System2663002663002023-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998470431Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
00197998470455Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
08800089451005Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2024-09-25
08800089446643ARIX System Bone ScrewJeil Medical CorporationNDG2024-03-19
00842188125362WashersTrimed, INC.NDG2023-01-05
05055662967555Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2022-05-25
00810028392106Arsenal FootTrilliant Surgical, LLCNDG2022-05-02
00810028392113Arsenal FootTrilliant Surgical, LLCNDG2022-05-02
00810028392120TigerTrilliant Surgical, LLCNDG2022-05-02
08800089420391INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
08800089420407INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
05055662964844Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2021-06-25
00885556784006EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784013EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784037EVOSSmith & Nephew, Inc.NDG2021-05-11
20885556746022SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746028SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746035SMART TSFSmith & Nephew, Inc.NDG2020-11-03
08806390891912Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891929Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891936Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390858014VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390858021VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865821Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865838Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390883641Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-02-18
08806390850742ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08806390862288ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815508ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815515ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12