FDA.reportPublic FDA data

Protean

Primary DI
00841506137582
Brand
Protean
Company
SKELETAL DYNAMICS L.L.C.
Model
Thread In Bending Rod, 1.5mm, Tall
Catalog number
PRT-BRT-015
Device description
Thread In Bending Rod, 1.5mm, Tall
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841506137582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506137582008415061375828415061375820841506137582

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

Contacts#

Phone, Email table
PhoneEmail
+1(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags#

DUNS number
869056148
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841506134895Threaded Hand NailDGA-THN-20DGA-THN-202026-04-29
00841506140193Threaded Hand NailDRVR-UQC-T8RDRVR-UQC-T8R2026-04-29
00841506140216Threaded Hand NailDRVR-CAN-T10RDRVR-CAN-T10R2026-04-29
00841506140223Threaded Hand NailDRVR-CAN-T8RDRVR-CAN-T8R2026-04-29
00841506141060Threaded Hand NailKWIR-DT-14171KWIR-DT-141712026-04-29
00841506141398Threaded Hand NailHTS-WPHTS-WP2026-04-29
00841506141428Threaded Hand NailKWIR-ST-07152KWIR-ST-071522026-04-29
00841506146546Threaded Hand NailRHS-20012CRHS-20012C2026-04-29
00841506146553Threaded Hand NailRHS-20014CRHS-20014C2026-04-29
00841506146560Threaded Hand NailRHS-20016CRHS-20016C2026-04-29
00841506146577Threaded Hand NailRHS-20018CRHS-20018C2026-04-29
00841506146584Threaded Hand NailRHS-20020CRHS-20020C2026-04-29
00841506146591Threaded Hand NailRHS-20022CRHS-20022C2026-04-29
00841506146607Threaded Hand NailRHS-20024CRHS-20024C2026-04-29
00841506146614Threaded Hand NailRHS-20026CRHS-20026C2026-04-29
00841506146621Threaded Hand NailRHS-20028CRHS-20028C2026-04-29
00841506146638Threaded Hand NailRHS-20032CRHS-20032C2026-04-29
00841506146645Threaded Hand NailRHS-20036CRHS-20036C2026-04-29
00841506146652Threaded Hand NailRHS-20040CRHS-20040C2026-04-29
00841506146669Threaded Hand NailRHS-20044CRHS-20044C2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162048neon3Ulrich GmbH & Co. KGLXH2026-06-08
04052536162079neon3Ulrich GmbH & Co. KGLXH2026-06-08
00198506091445ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-05
00199150076161Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-05
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03