FDA.reportPublic FDA data

AlloWedge

Primary DI
00191083047386
Brand
AlloWedge
Company
Rti Surgical, Inc.
Model
55-MALLET
Catalog number
55-MALLET
Device description
Mallet - Foot and Ankle Wedge
Published
2024-10-14
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
HXLMALLET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191083047386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191083047386001910830473861910830473860191083047386

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(386)418-8888labeling@rtix.com

Regulatory Flags#

DUNS number
117560455
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191083047676RapidEase™4564SC4564SC2023-11-03
00191083047683RapidEase™4561SC4561SC2023-11-03
00191083024554Streamline TL Spinal Fixation System10-55-PR-10010-55-PR-1002021-06-25
00191083024585Streamline TL Spinal Fixation System10-55-PR-11510-55-PR-1152021-06-25
00191083024608Streamline TL Spinal Fixation System10-55-PR-12510-55-PR-1252021-06-25
00191083024615Streamline TL Spinal Fixation System10-55-PR-13010-55-PR-1302021-06-25
00191083024639Streamline TL Spinal Fixation System10-55-PR-14010-55-PR-1402021-06-25
00191083024653Streamline TL Spinal Fixation System10-55-PR-15010-55-PR-1502021-06-25
00191083024707Streamline TL Spinal Fixation System10-55-PR-5510-55-PR-552021-06-25
00191083024745Streamline TL Spinal Fixation System10-55-PR-7510-55-PR-752021-06-25
00191083024769Streamline TL Spinal Fixation System10-55-PR-8510-55-PR-852021-06-25
00191083024776Streamline TL Spinal Fixation System10-55-PR-9010-55-PR-902021-06-25
00191083024806Streamline TL Spinal Fixation System10-55-RH-15010-55-RH-1502021-06-25
00191083024844Streamline TL Spinal Fixation System10-55-RHC-20010-55-RHC-2002021-06-25
00191083024851Streamline TL Spinal Fixation System10-55-RHC-40010-55-RHC-4002021-06-25
00191083024868Streamline TL Spinal Fixation System10-55-RHC-60010-55-RHC-6002021-06-25
00191083024875Streamline TL Spinal Fixation System10-55-RR-10010-55-RR-1002021-06-25
00191083024882Streamline TL Spinal Fixation System10-55-RR-11010-55-RR-1102021-06-25
00191083024899Streamline TL Spinal Fixation System10-55-RR-3510-55-RR-352021-06-25
00191083024905Streamline TL Spinal Fixation System10-55-RR-4010-55-RR-402021-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462912995evonosevonos GmbH & Co. KGHXL2026-08-19
04054462913008evonosevonos GmbH & Co. KGHXL2026-08-19
04054462913015evonosevonos GmbH & Co. KGHXL2026-08-19
04054462905553evonosevonos GmbH & Co. KGHXL2026-08-18
04054462907618evonosevonos GmbH & Co. KGHXL2026-08-18
04054462907625evonosevonos GmbH & Co. KGHXL2026-08-18
B382SD5422310000Surgical DirectSurgical Direct, Inc.HXL2026-08-03
B382SD914542230Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD9145561200Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD9145571030Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD914569410000Surgical DirectSurgical Direct, Inc.HXL2026-07-27
00817493028257Hive Standalone Cervical SystemNanohive Medical LLCHXL2026-05-08
00840311245635Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXL2026-03-18
00810158218871PRINCETONPrinceton Medical Group, Inc.HXL2026-02-16
B382SD9145561170Surgical DirectSurgical Direct, Inc.HXL2026-02-16
B382SD9141061010Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145561160Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD914556300Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145970180Surgical DirectSurgical Direct, Inc.HXL2026-02-09
03662663083683ActivLHighridge Medical, LLCHXL2026-02-03
00840180545829General InstrumentsALPHATEC SPINE, INC.HXL2026-01-29
00810158218482PRINCETONPrinceton Medical Group, Inc.HXL2026-01-15
00841731135322Redemption VILEX LLCHXL2026-01-12
03662663154543SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663154581SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663155601Zyston Interbody Spacer SystemHighridge Medical, LLCHXL2025-12-29
00840194418157PediflexORTHOPEDIATRICS CORP.HXL2025-12-11
03662663217002Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHXL2025-11-17
03662663267199Timberline Lateral Fusion SystemHighridge Medical, LLCHXL2025-11-16
00887868294976TM Ardis Interbody SystemHighridge Medical, LLCHXL2025-11-14