Logical C-Series

GUDID 09348215005245

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell

Primary Device ID	09348215005245
NIH Device Record Key	f8804161-b117-47a9-8e2a-7687034eeda0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Logical C-Series
Version Model Number	111-12-4948
Company DUNS	751993028
Company Name	SIGNATURE ORTHOPAEDICS PTY LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215005245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153131

FDA Product Code

KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-09-09
Device Publish Date	2016-07-07

On-Brand Devices [Logical C-Series]

09348215005351	111-12-4970
09348215005344	111-12-4968
09348215005337	111-12-4966
09348215005320	111-12-4964
09348215005313	111-12-4962
09348215005306	111-12-4960
09348215005290	111-12-4958
09348215005283	111-12-4956
09348215005276	111-12-4954
09348215005269	111-12-4952
09348215005252	111-12-4950
09348215005245	111-12-4948
09348215005238	111-12-4946
09348215005221	111-12-4944
09348215005191	111-12-4370
09348215005184	111-12-4368
09348215005177	111-12-4366
09348215005160	111-12-4364
09348215005153	111-12-4362
09348215005146	111-12-4360
09348215005139	111-12-4358
09348215005122	111-12-4356
09348215005115	111-12-4354
09348215005108	111-12-4352
09348215005092	111-12-4350
09348215005085	111-12-4348
09348215005078	111-12-4346
09348215005061	111-12-4344
09348215005030	111-12-4070
09348215005023	111-12-4068
09348215005016	111-12-4066
09348215005009	111-12-4064
09348215004996	111-12-4062
09348215004989	111-12-4060
09348215004972	111-12-4058
09348215004965	111-12-4056
09348215004958	111-12-4054
09348215004941	111-12-4052
09348215004934	111-12-4050
09348215004927	111-12-4048
09348215004910	111-12-4046
09348215004903	111-12-4044