FDA.report

Spinal System

Primary DI
00880304837584
Brand
Spinal System
Company
BIOMET SPINE LLC
Model
133M1450
Catalog number
133M1450
Published
2018-09-25
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
false

Related Records

Contact Domains

Product Codes

CodeName
HTFCURETTE

Product Code Classifications

CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304837584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304837584008803048375848803048375840880304837584

GMDN Terms

TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags

DUNS number
018577570
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

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03662663063258Vital Spinal Fixation System727M64002024-05-10
03662663063265Vital Spinal Fixation System727M65102024-05-10
03662663063272Vital Spinal Fixation System727M74002024-05-10
03662663063289Vital Spinal Fixation System727M75102024-05-10
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03662663063302Vital Spinal Fixation System727M85102024-05-10
03662663063524Vital Spinal Fixation System727M54012024-05-10
03662663063531Vital Spinal Fixation System727M54022024-05-10
03662663063548Vital Spinal Fixation System727M55112024-05-10
03662663063555Vital Spinal Fixation System727M55122024-05-10
03662663063562Vital Spinal Fixation System727M64012024-05-10
03662663063579Vital Spinal Fixation System727M64022024-05-10
03662663063586Vital Spinal Fixation System727M65112024-05-10
03662663063593Vital Spinal Fixation System727M65122024-05-10
03662663063609Vital Spinal Fixation System727M74012024-05-10
03662663063616Vital Spinal Fixation System727M74022024-05-10
03662663063623Vital Spinal Fixation System727M75112024-05-10
03662663063630Vital Spinal Fixation System727M75122024-05-10

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24026704941708PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
00192896122871Spoon CuretteSONTEC INSTRUMENTS, INC.HTF2026-03-19
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00190776393229MillenniumAvalign Technologies, Inc.HTF2026-03-04
00810168190297NAPACIFIC INSTRUMENTS, INC.HTF2026-03-03
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00190776416447MillenniumAvalign Technologies, Inc.HTF2026-02-16
00190776416669MillenniumAvalign Technologies, Inc.HTF2026-02-16
03662663109475Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109512Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109529Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
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03662663109550Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109567Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
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00190776416027MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416041MillenniumAvalign Technologies, Inc.HTF2026-02-06
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03662663083584ActivLHighridge Medical, LLCHTF2026-02-03
03662663083591ActivLHighridge Medical, LLCHTF2026-02-03
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03662663083621ActivLHighridge Medical, LLCHTF2026-02-03