AccessGUDID - DEVICE: APEX (07613154493104)

GUDID

Device Identifier (DI) Information

Brand Name: APEX
Version or Model: 5013-8-150S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5013-8-150S
Company Name: Stryker Trauma SA

Primary DI Number: 07613154493104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481999654 *Terms of Use

Device Description: Self-drilling Half Pin

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Orthopaedic bone pin, non-bioabsorbable	A small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic bone pin, non-bioabsorbable

A small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
JDW	PIN, FIXATION, THREADED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061493	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Length: 150.0 Millimeter
Device Size Text, specify: Diameter: 4.0 Millimeter

Device Record Status

Public Device Record Key: a4ec21e0-8e80-487b-8301-4ef9dd93d075
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015