DEVICE: G7® (00887868462535)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47815 | Orthopaedic implant aiming/guiding block, reusable |
A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
LWZ | TISSUE GRAFT OF LESS THAN 6MM |
OQH | Hip, semi-constrained, cemented, metal/polymer + additive, cemented |
PBI | prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
OQI | Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121874 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c7132cfd-d411-405f-b71b-e8d98397f026
May 30, 2025
2
April 30, 2021
May 30, 2025
2
April 30, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com