AccessGUDID - DEVICE: Pro-fix™ Precision Fixation System (D765PFT451)

GUDID

Device Identifier (DI) Information

Brand Name: Pro-fix™ Precision Fixation System
Version or Model: PFT4-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Osteogenics Biomedical Inc

Primary DI Number: D765PFT451
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 123853058 *Terms of Use

Device Description: 1.5 mm x 4.0 mm self-drilling titanium alloy tenting 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:	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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46638	Craniofacial bone screw, non-bioabsorbable	A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZL	Screw, Fixation, Intraosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093719	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: 4.0 Millimeter

Device Record Status

Public Device Record Key: 437bba24-6313-43fc-abf6-ee28caa879cd
Public Version Date: June 19, 2024
Public Version Number: 4
DI Record Publish Date: January 13, 2021