AccessGUDID - DEVICE: Apelo® / Apelo® MIS (M68111060265400)

GUDID

Device Identifier (DI) Information

Brand Name: Apelo® / Apelo® MIS
Version or Model: 1106-02-6540
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1106-02-6540
Company Name: ATLAS SPINE, INC.

Primary DI Number: M68111060265400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140801007 *Terms of Use

Device Description: 6.5mm x 40mm Mono Screw

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56642	Orthopaedic bone screw, non-bioabsorbable, non-sterile	A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072426	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 40 Millimeter

Device Record Status

Public Device Record Key: ae889160-cc04-4fb4-992f-8e09733e08fe
Public Version Date: February 19, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2014