FDA.reportPublic FDA data

Caliber Intramedullary Fixation System

Primary DI
00810135962940
Brand
Caliber Intramedullary Fixation System
Company
NVision Biomedical Technologies, Inc.
Model
CLN-45-80
Device description
4.5mm implant 80mm long. The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm to 5.0mm in lengths from 50mm to 120mm.
Published
2025-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242896000Caliber Intramedullary Fixation SystemNvision Biomedical Technologies2025-02-05HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810135962940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810135962940008101359629408101359629400810135962940

GMDN Terms#

Term, Definition table
TermDefinition
Clavicle intramedullary nail-like rodA rod intended to be implanted into the intramedullary canal of the clavicle bone for the fixation of a fracture(s) and/or treatment of malunion(s)/nonunion(s). Also referred to as a nail or pin, it may be straight, curved or bendable, and might be partially-threaded, stabilised with a bone screw, and/or incorporate expandable hook-like features for stabilisation; it is typically made of stainless steel. Devices intended to assist with stabilisation (e.g., a bone screw) may be included with the rod. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-598-5938Denisealva@nvisionbiomed.com
210-598-5687marissacortez@nvisionbiomed.com
210-598-5687Jenniferoconnell@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005663762ToejackTB-30-20L2026-07-29
00810005663779ToejackTB-30-22L2026-07-29
00810005665711ToejackTB-30-18L2026-07-29
00810005668828TrigonTB-30-18N2026-07-29
00810005668835ToeJackTB-30-20N2026-07-29
00810005668842ToejackTB-30-22N2026-07-29
00810135961196ToeJackTJB-30-302026-07-29
00810135961202ToejackTJB-1000T-D30S2026-07-29
00810135961219ToejackTJB-1000T-D30C2026-07-29
00810135961226ToejackTJB-1000T-T8CI2026-07-29
00810135961233ToejackTJB-1001T-DPG2026-07-29
00810135961257ToejackTJB-1001T-SG032026-07-29
00810135961288ToejackTJB-1000T-PKS2026-07-29
00810135961769ToejackTJB-30-14HL2026-07-29
00810135961776ToejackTJB-30-16HL2026-07-29
00810135961783ToejackTJB-30-18HL2026-07-29
00810135961790ToejackTJB-30-20HL2026-07-29
00810135961806ToejackTJB-30-22HL2026-07-29
00810135963121ToeJack Bunion Correction SystemTJB-1000C-1052026-07-29
00810135965088ToeJack Bunion Correction SystemTJB-1000C-1042026-07-29

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