mild Device Kit

GUDID B235MDK00020

STRYKER CORPORATION

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device IDB235MDK00020
NIH Device Record Key72fd18dc-6ecd-4caf-a3f2-41a6b711c158
Commercial Distribution StatusIn Commercial Distribution
Brand Namemild Device Kit
Version Model NumberMDK-0002
Company DUNS196548481
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB235MDK00020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-08-07
Device Publish Date2024-06-19

Devices Manufactured by STRYKER CORPORATION

B235MDK00020 - mild Device Kit2025-08-07
B235MDK00020 - mild Device Kit2025-08-07
07613327262995 - XIA II2025-07-17 CORONAL BENDER LEFT
07613327263015 - XIA II2025-07-17 CORONAL BENDER RIGHT
07613327661989 - KNOTILUS+2025-06-24 2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
07613327661996 - KNOTILUS+2025-06-24 2.4X8.9MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
07613327662009 - KNOTILUS+2025-06-24 2.4X11.3MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
07613327662016 - KNOTILUS+2025-06-24 2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
07613327662023 - KNOTILUS+2025-06-24 2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE

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