DEVICE: G7 STRAIGHT INSERTER THREADED SHAFT (00880304551602)

Device Identifier (DI) Information

G7 STRAIGHT INSERTER THREADED SHAFT
110003452
In Commercial Distribution
110003452
Biomet Orthopedics, LLC
00880304551602
GS1

1
129278169 *Terms of Use
No description.
CLOSE

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?
12696 Orthopaedic inorganic implant inserter/extractor, reusable
A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
PBI prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
OQI Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, 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
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121874 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5fc2acec-8162-4a53-8199-50d21df83b40
May 30, 2025
9
October 27, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)348-9500
customerservice@zimmerbiomet.com
CLOSE