FDA.reportPublic FDA data

LONG REDUCTION TOOL

Primary DI
00887868027628
Brand
LONG REDUCTION TOOL
Company
Biomet Orthopedics, LLC
Model
2810-01-007
Catalog number
281001007
Published
2020-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868027628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868027628008878680276288878680276280887868027628

GMDN Terms#

Term, Definition table
TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
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
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06438408012822Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012839Inion CompressOn™ InstrumentInion OyFZX2026-08-07
00840606191838Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00840606191845Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00190376544496InvictusALPHATEC SPINE, INC.FZX2026-07-30
03701089528054AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089542548AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543316AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543330AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543354AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543378AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543682AMPLITUDEAMPLITUDE SASFZX2026-07-29
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03700569674342Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674281Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
03700569674298Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
00842188132568Tools-AFSTrimed, INC.FZX2026-07-24
00841731153128ARTEMIS FUZEVILEX LLCFZX2026-07-22
00888118147226LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147233LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147240LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21