FDA.reportPublic FDA data

Carilaginator

Primary DI
00842078130261
Brand
Carilaginator
Company
EXTREMITY MEDICAL, LLC
Model
170-02141
Device description
Small Curved, Convex (3D) Cartilaginator
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842078130261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842078130261008420781302618420781302610842078130261

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, reciprocating, single-useA surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to be attached to a reciprocating power tool handpiece to scrape and smooth the surface of bone during a surgical procedure. It has grooves/teeth along all or part of the distal working end and is made of metal [e.g., stainless steel, titanium (Ti)]; it is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
832720358
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
true
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
00842078125724Carilaginator168-050102026-06-09
00842078125748Carilaginator168-050202026-06-09
00842078130315Carilaginator170-021402026-06-09
00842078130452Carilaginator170-012512026-06-09
00842078130490Carilaginator170-012502026-06-09
00842078130537Carilaginator170-000112026-06-09
00842078134054Carilaginator168-05010-S2026-06-09
00842078134061Carilaginator168-05020-S2026-06-09
00842078134078Carilaginator170-00011-S2026-06-09
00842078134085Carilaginator170-01250-S2026-06-09
00842078134092Carilaginator170-01251-S2026-06-09
00842078134108Carilaginator170-02140-S2026-06-09
00842078134115Carilaginator170-02141-S2026-06-09
00842078136553MetaFore171-25012-S2026-01-22
00842078136560MetaFore171-25014-S2026-01-22
00842078136577MetaFore171-25016-S2026-01-22
00842078136584MetaFore171-25018-S2026-01-22
00842078136591MetaFore171-25020-S2026-01-22
00842078136607MetaFore171-25022-S2026-01-22
00842078136614MetaFore171-25024-S2026-01-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850078396365PFT Adapter, DS, Mariner,105 in-lb (228-TXRX-009)Eca Medical InstrumentsHWE2026-10-20
00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)Eca Medical InstrumentsHWE2026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
03700879515687Airlock®NOVASTEPHWE2026-08-25
08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
00850083430108SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
10888857578135Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578142Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578159Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578166Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578210Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578227Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578234Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578241Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578760Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578784Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578807Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578821Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20