FDA.reportPublic FDA data

PolyLock SmallBone

Primary DI
00840124507623
Brand
PolyLock SmallBone
Company
FUSION ORTHOPEDICS, LLC
Model
TN-TB-7104
Catalog number
TN-TB-7104
Device description
(not in use)
Published
2023-06-12
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
NJAAccessory, System, External Fixator, Containing Antimicrobial Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJAAccessory, System, External Fixator, Containing Antimicrobial AgentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124507623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124507623008401245076238401245076230840124507623

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.

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
00840124514133TopLockFUSION ORTHOPEDICS, LLCNJA2025-09-25
00840124514140TopLockFUSION ORTHOPEDICS, LLCNJA2025-09-25
00840124521551FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521568FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521575FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521582FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521636FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124521643FuzeFix Max FTFUSION ORTHOPEDICS, LLCNJA2025-09-17
00840124518919FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518926FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518933FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124519152IntraLockFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124519176IntraLockFUSION ORTHOPEDICS, LLCNJA2025-05-14
00840124518896FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-13
00840124518902FuzeFix LargeFUSION ORTHOPEDICS, LLCNJA2025-05-13