FDA.reportPublic FDA data

Loading Block

Primary DI
04054896032597
Brand
Loading Block
Company
Silony Medical GmbH
Model
RI-2046
Catalog number
RI-2046
Device description
ROCCIA Implant Loading Block, 46mm
Published
2026-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
04054896032597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896032597040548960325974054896032597

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft packing blockA device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342538826
Device count
1
DM exempt
false
Premarket exempt
true
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
04054896000770AwlVI-1010VI-10102026-09-18
04054896000787AwlVI-1020VI-10202026-09-18
04054896000831Control GaugesVI-1040VI-10402026-09-18
04054896000855Implant ModifierVI-1160VI-11602026-09-18
04054896000862Implant ModifierVI-1250VI-12502026-09-18
04054896000879Implant ModifierVI-1270VI-12702026-09-18
04054896000886Forceps and ClampsVI-1320VI-13202026-09-18
04054896000893(Re-) Positioning ToolsVI-1340VI-13402026-09-18
04054896000909(Re-) Positioning ToolsVI-1360VI-13602026-09-18
04054896000916(Re-) Positioning ToolsVI-1361VI-13612026-09-18
04054896000923AdapterVI-1362VI-13622026-09-18
04054896000930(Re-) Positioning ToolsVI-1363VI-13632026-09-18
04054896000947AdapterVI-1410VI-14102026-09-18
04054896000985Torque LimiterVI-1450VI-14502026-09-18
04054896000992(Re-) Positioning ToolsVI-1510VI-15102026-09-18
04054896001005Forceps and ClampsVI-1530VI-15302026-09-18
04054896001012Implant ModifierVI-1610VI-16102026-09-18
04054896001029Forceps and ClampsVI-1620VI-16202026-09-18
04054896001036Forceps and ClampsVI-1630VI-16302026-09-18
04054896001067Forceps and ClampsVI-1820VI-18202026-09-18

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10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
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B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
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08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
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