FDA.reportPublic FDA data

PERLA ® TL

Primary DI
07640375234858
Brand
PERLA ® TL
Company
SpineArt SA
Model
TLF-IN 15 30-N
Catalog number
TLF-IN 15 30-N
Device description
CORONAL BENDER - RIGHT
Published
2025-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXWBender

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640375234858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640375234858076403752348587640375234858

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640221373021PERLA NAVNAV-IN 11 50-NNAV-IN 11 50-N2026-05-07
07640221373038PERLA ® TLHAN-FI BA 50-N2026-05-07
07640221373045PERLA ® TLTLF-IN 01 60-N2026-05-07
07640221373052PERLA NAVNAV-IN 43 30-NNAV-IN 43 30-N2026-05-07
07640221373069PERLA NAVNAV-IN 43 60-NNAV-IN 43 60-N2026-05-07
07640221373076PERLA ® TLTLF-IN 03 70-N2026-05-07
07640221373083PERLA ® TLTLF-IN 12 00-N2026-05-07
07640221373090PERLA ® TLTLF-IN 04 70-N2026-05-07
07640221373113PERLA NAVNAV-IN 41 75-NNAV-IN 41 75-N2026-05-07
07640221373120PERLA NAVNAV-IN 41 80-NNAV-IN 41 80-N2026-05-07
07640221373137PERLA NAVNAV-IN 41 85-NNAV-IN 41 85-N2026-05-07
07640221373144PERLA NAVNAV-IN 41 90-NNAV-IN 41 90-N2026-05-07
07640221373151PERLA NAVNAV-IN 41 95-NNAV-IN 41 95-N2026-05-07
07640221373168PERLA NAVNAV-IN 41 00-NNAV-IN 41 00-N2026-05-07
07640221373175PERLA NAVNAV-IN 41 05-NNAV-IN 41 05-N2026-05-07
07640221373182PERLA NAVNAV-IN 41 10-NNAV-IN 41 10-N2026-05-07
07640221373199PERLA NAVNAV-IN 41 15-NNAV-IN 41 15-N2026-05-07
07640221373205PERLA NAVNAV-IN 41 20-NNAV-IN 41 20-N2026-05-07
07640221373212PERLA NAVNAV-IN 41 25-NNAV-IN 41 25-N2026-05-07
07640221373229PERLA NAVNAV-IN 42 70-NNAV-IN 42 70-N2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840180546178General InstrumentsALPHATEC SPINE, INC.HXW2026-05-15
00840180546192General InstrumentsALPHATEC SPINE, INC.HXW2026-05-15
00840311251308Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HXW2026-04-30
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
00810111225281Instrument TrayTreace Medical Concepts, Inc.HXW2026-03-30
07640332475553CURE 2.0 ACPSpineArt SAHXW2025-11-12
07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
10705034576985N/ADEPUY SPINE, LLCHXW2024-12-16
10887587077635NASynthes GmbHHXW2024-08-21
10887587077963NASynthes GmbHHXW2024-08-21
00763000733117Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-12-18
00643169273559n/aMEDTRONIC SOFAMOR DANEK, INC.HXW2022-11-14
00613994860415Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-10-10
00613994860422Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-10-10
G079C5040000010Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000020Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000030Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
08800089415212INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089417308INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089418268INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089402755Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHXW2021-05-28
10886982277022NASynthes GmbHHXW2020-12-11
10884389956212MedlineMEDLINE INDUSTRIES, INC.HXW2020-08-21
20705034734191NASynthes GmbHHXW2019-12-18
20705034734214NASynthes GmbHHXW2019-08-20
20705034734221NASynthes GmbHHXW2019-08-20
10705034548470NADEPUY SPINE, LLCHXW2019-02-20