FDA.reportPublic FDA data

EASYSTEP

Primary DI
07613327170726
Brand
EASYSTEP
Company
Stryker GmbH
Model
XFO130022
Catalog number
XFO130022
Device description
Drill Bit with Stop
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JDRStaple, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160813000EasyStepStryker GmbH2016-07-26JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327170726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327170726076133271707267613327170726

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227223SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227247SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111227254SpeedMTP SelectTreace Medical Concepts, Inc.JDR2026-05-13
00810111224062TMC SpeedMTPTreace Medical Concepts, Inc.JDR2026-03-30
00810111224833TMC Nanoplasty SystemTreace Medical Concepts, Inc.JDR2025-10-10
00811714036458Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
00811714036465Thunderbolt RESPONSIVE ORTHOPEDICS LLCJDR2025-05-14
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
00810111223683SpeedPlate - SpeedAkinTreace Medical Concepts, Inc.JDR2025-01-27
00810111223485TMC SpeedMTPTreace Medical Concepts, Inc.JDR2024-11-18
07630037889397APTUSMedartis AGJDR2023-03-03
10888867042633Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042640Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042671Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042688Arthrex®ARTHREX, INC.JDR2021-12-03
10888867042695Arthrex®ARTHREX, INC.JDR2021-12-03
00811714035345Thunderbolt Suture AssemblyRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
00811714035352Thunderbolt PlateRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
07630971238039MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238046MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238053MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238060MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238077MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238084MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238091MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238107MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238114MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238121MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
00815432025138MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2018-08-06