PolyLock SmallBone

Primary DI
00840124507548
Brand
PolyLock SmallBone
Company
FUSION ORTHOPEDICS, LLC
Model
TB-TB-1000
Catalog number
TB-TB-1000
Device description
TailorsLock Plate (Old)
Published
2023-06-09
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
CodeName
NDFPlate, Fixation, Bone, Non-Spinal, Metallic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDFPlate, Fixation, Bone, Non-Spinal, MetallicOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124507548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124507548008401245075488401245075480840124507548

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, bioabsorbableA small, implantable sheet of firm material that is attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device is typically used for smaller post-traumatic or pathological orthopaedic fractures (e.g., of the hand or wrist). It may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124525603FibFixCD-FN-4037-SCD-FN-4037-S2026-05-11
00840124525610FibFixCD-FN-4047-SCD-FN-4047-S2026-05-11
00840124525627FibFixCD-FN-4057-SCD-FN-4057-S2026-05-11
00840124525634FibFixCD-FN-4037CD-FN-40372026-05-11
00840124525641FibFixCD-FN-4047CD-FN-40472026-05-11
00840124525658FibFixCD-FN-4057CD-FN-40572026-05-11
00840124521407Metalogix9003179003172025-09-30
00840124521414Metalogix9003209003202025-09-30
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525573FuzeFix LargeTN-FT-7070TN-FT-70702026-04-23
00840124525580FuzeFix LargeTN-FT-7024TN-FT-70242026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00819034022557TalarLift STS CD-TL-5050CD-TL-50502019-04-29
00840124525535Metalogix RevolutionTN-TR-0092TN-TR-00922026-04-17
00840124516113FibFixFN-SS-4014FN-SS-40142026-04-09
00840124516120FibFixFN-SS-40162026-04-09
00840124516137FibFixFN-SS-4018FN-SS-40182026-04-09
00840124516144FibFixFN-SS-4020FN-SS-40202026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124513730PolyLock Small BoneFUSION ORTHOPEDICS, LLCNDF2024-08-01
00889024054066NAZimmer, Inc.NDF2017-10-02
00889024053830NAZimmer, Inc.NDF2017-10-02
00889024053847NAZimmer, Inc.NDF2017-10-02
00889024053854NAZimmer, Inc.NDF2017-10-02
00889024053946NAZimmer, Inc.NDF2017-10-02
00889024053953NAZimmer, Inc.NDF2017-10-02
00889024053960NAZimmer, Inc.NDF2017-10-02
00889024053977NAZimmer, Inc.NDF2017-10-02
00889024053984NAZimmer, Inc.NDF2017-10-02
00889024053991NAZimmer, Inc.NDF2017-10-02
00889024054004NAZimmer, Inc.NDF2017-10-02
00889024054011NAZimmer, Inc.NDF2017-10-02
00889024054028NAZimmer, Inc.NDF2017-10-02
00889024054042NAZimmer, Inc.NDF2017-10-02
00889024054059NAZimmer, Inc.NDF2017-10-02
00889024054073NAZimmer, Inc.NDF2017-10-02
00889024054097NAZimmer, Inc.NDF2017-10-02
00889024054103NAZimmer, Inc.NDF2017-10-02
00887868089916DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090011DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090035DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090042DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090059DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090066DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090073DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090080DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090097DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090103DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24
00887868090110DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDF2015-10-24