DEVICE: G7 POLY LINER REMOVAL SCREW (00880304566385)
Device Identifier (DI) Information
G7 POLY LINER REMOVAL SCREW
010002751
In Commercial Distribution
010002751
Biomet Orthopedics, LLC
010002751
In Commercial Distribution
010002751
Biomet Orthopedics, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
36235 | Manual surgical rotary handpiece, reusable |
A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PBI | prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
OQI | Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
OQH | Hip, semi-constrained, cemented, metal/polymer + additive, cemented |
OQG | Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented |
LWZ | TISSUE GRAFT OF LESS THAN 6MM |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K121874 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6e577e91-87df-4b83-99ad-9fbd3f6b4b2e
May 30, 2025
7
September 23, 2016
May 30, 2025
7
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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