Home GUDID 00840124513730
PolyLock Small Bone
Primary DI 00840124513730
Brand PolyLock Small Bone
Company FUSION ORTHOPEDICS, LLC
Model SB-TB-1000
Catalog number SB-TB-1000
Device description TailorsLock Plate
Published 2024-08-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NDF Plate, Fixation, Bone, Non-Spinal, Metallic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDF Plate, Fixation, Bone, Non-Spinal, Metallic Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840124513730 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840124513730 00840124513730 840124513730 0840124513730
GMDN Terms# Term, Definition table Term Definition Orthopaedic fixation plate, bioabsorbable A non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080307067 Device count 1 DM exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Donation ID number true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840124507548 PolyLock SmallBone FUSION ORTHOPEDICS, LLC NDF 2023-06-09 00889024054066 NA Zimmer, Inc. NDF 2017-10-02 00889024053830 NA Zimmer, Inc. NDF 2017-10-02 00889024053847 NA Zimmer, Inc. NDF 2017-10-02 00889024053854 NA Zimmer, Inc. NDF 2017-10-02 00889024053946 NA Zimmer, Inc. NDF 2017-10-02 00889024053953 NA Zimmer, Inc. NDF 2017-10-02 00889024053960 NA Zimmer, Inc. NDF 2017-10-02 00889024053977 NA Zimmer, Inc. NDF 2017-10-02 00889024053984 NA Zimmer, Inc. NDF 2017-10-02 00889024053991 NA Zimmer, Inc. NDF 2017-10-02 00889024054004 NA Zimmer, Inc. NDF 2017-10-02 00889024054011 NA Zimmer, Inc. NDF 2017-10-02 00889024054028 NA Zimmer, Inc. NDF 2017-10-02 00889024054042 NA Zimmer, Inc. NDF 2017-10-02 00889024054059 NA Zimmer, Inc. NDF 2017-10-02 00889024054073 NA Zimmer, Inc. NDF 2017-10-02 00889024054097 NA Zimmer, Inc. NDF 2017-10-02 00889024054103 NA Zimmer, Inc. NDF 2017-10-02 00887868089916 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090011 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090035 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090042 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090059 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090066 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090073 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090080 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090097 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090103 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24 00887868090110 DYNAFIX VS OSTEOTOMY SYSTEM Biomet Orthopedics, LLC NDF 2015-10-24