AccessGUDID - DEVICE: Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral (09351327000060)

GUDID

Device Identifier (DI) Information

Brand Name: Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral
Version or Model: 1248-1500, 1248-1700, 1250-1100,1250-1200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OPTIMIZED ORTHO PTY LTD

Primary DI Number: 09351327000060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 745735175 *Terms of Use

Device Description: Patient Specific Acetabular Guide ,Trial Acetabulum,Patient Specific Femoral Guide and Trial Femoral Head

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60826	Custom-made orthopaedic/craniofacial surgical guide	A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBF	Orthopaedic Surgical Planning And Instrument Guides
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152893	000
K181061	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
No Device Sizes

Device Record Status

Public Device Record Key: 5198be01-ffed-4618-9eef-1aeffb302fa8
Public Version Date: December 04, 2020
Public Version Number: 2
DI Record Publish Date: April 18, 2019