FDA.reportPublic FDA data

RELJA Reduction Clamp (Left and Right)

Primary DI
00860005968817
Brand
RELJA Reduction Clamp (Left and Right)
Company
Relja Innovations LLC
Model
RI-CC-LR
Catalog number
RI-CC-LR
Device description
The Relja Innovations Reduction Clamp is a manual surgical instrument intended to position and compress the metatarsal joints during an orthopedic surgery.
Published
2024-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860005968817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860005968817008600059688178600059688170860005968817

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-447-3552rob@reljainnovations.com

Regulatory Flags#

DUNS number
113596350
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005968848RELJA Innovations Lapidus Screw KitRI-LAP-LSK2026-01-26
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRI-NS-152025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18RI-NS-182025-09-19
00860005968800MIS Precision Chevron Bunion SystemRI-2427-C2022-12-21

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