FDA.reportPublic FDA data

PathFinder NXT®

Primary DI
00880304989009
Brand
PathFinder NXT®
Company
BIOMET SPINE LLC
Model
3552-370
Catalog number
3552-370
Published
2018-02-15
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
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304989009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304989009008803049890098803049890090880304989009

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags#

DUNS number
018577570
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304860544Vitality®+ Osteotomy732M2129732M21292018-06-05
00880304860551Vitality®+ Osteotomy732M2221732M22212018-06-05
00880304860568Vitality®+ Osteotomy732M2224732M22242018-06-05
00880304860575Vitality®+ Osteotomy732M2226732M22262018-06-05
00880304860582Vitality®+ Osteotomy732M2229732M22292018-06-05
00888480489450LINEUM OCT SPINE SYSTEM14-52501314-5250132020-10-15
00888480511564LINEUM OCT SPINE SYSTEM14-52505414-5250542020-07-07
00888480207542POLARIS 5.5 SPINAL SYSTEM2000-23252000-23252015-10-24
00880304964143Polaris™ 6.35 Spinal System14-513730R14-513730R2020-11-10
00880304964433Polaris™ 6.35 Spinal System14-513555R14-513555R2020-11-10
03662663058155Spine System14-50077114-5007712021-12-17
03662663058162Spine System14-50077214-5007722021-12-17
03662663058179Spine System14-50077314-5007732021-12-17
03662663058186Spine System14-50077414-5007742021-12-17
03662663058193Spine System14-50077514-5007752021-12-17
03662663058209Spine System14-50077614-5007762021-12-17
03662663058216Spine System14-50077714-5007772021-12-17
03662663058223Spine System14-50077814-5007782021-12-17
03662663058230Spine System14-50077914-5007792021-12-17
03662663058247Spine System14-50078014-5007802021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115932508Tower Guide STPREMIA SPINE LTDMNI2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDMNH2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDNKB2026-07-23
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCNKB2026-07-23
00840019935319Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019935364Reform TiPRECISION SPINE, INC.NKB2019-10-07
00840019934800Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934817Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934824Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934831Reform TiPRECISION SPINE, INC.NKB2019-10-04
00840019934725Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934732Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934749Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934756Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934763Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934770Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934787Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934794Reform TiPRECISION SPINE, INC.NKB2019-09-25
00840019934251Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934268Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934275Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934282Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934299Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934305Reform TIPRECISION SPINE, INC.NKB2019-09-10
00840019934312Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934329Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934336Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934343Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934350Reform TiPRECISION SPINE, INC.NKB2019-09-10
00840019934367Reform TIPRECISION SPINE, INC.NKB2019-09-10