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
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
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