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
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
00840124513730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124513730008401245137308401245137300840124513730

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, bioabsorbableA 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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124516779FibFixTN-FN-9000TN-FN-90002026-04-09
00840124517783FibFixTN-FN-9000-STN-FN-9000-S2026-04-09
00840124521773PolyLock MidfootTN-CA-2501TN-CA-25012025-10-02
00840124521780PolyLock MidfootTN-CA-2004TN-CA-20042025-10-02
00840124521797PolyLock MidfootTN-CA-2003TN-CA-20032025-10-02
00840124521803PolyLock MidfootTN-CA-2002TN-CA-20022025-10-02
00840124521810PolyLock MidfootTN-CA-2001TN-CA-20012025-10-02
00840124521827PolyLock MidfootTN-CA-2503TN-CA-25032025-10-02
00840124521834PolyLock MidfootTN-CA-2502TN-CA-25022025-10-02
00840124521841PolyLock MidfootTN-CA-2504TN-CA-25042025-10-02
00840124525467FibFixTN-FN-9000-ATN-FN-9000-A2026-04-09
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00840124519220IntraLockTN-LL-5861TN-LL-58612025-05-14
00840124519244LapiLockTN-LL-5075TN-LL-50752025-05-14
00840124519251LapiLockTN-LL-5085TN-LL-50852025-05-14
00840124519268LapiLockTN-LL-5185TN-LL-51852025-05-14
00840124519275LapiLockTN-LL-5285TN-LL-52852025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124507548PolyLock SmallBoneFUSION ORTHOPEDICS, LLCNDF2023-06-09
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