FDA.reportPublic FDA data

PolyLock

Primary DI
00840124500884
Brand
PolyLock
Company
FUSION ORTHOPEDICS, LLC
Model
TN-SB-8060
Catalog number
TN-SB-8060
Device description
Recon Wire Depth Gauge SB
Published
2020-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840124500884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124500884008401245008848401245008840840124500884

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080307067
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840124525603FibFixCD-FN-4037-SCD-FN-4037-S2026-05-11
00840124525610FibFixCD-FN-4047-SCD-FN-4047-S2026-05-11
00840124525627FibFixCD-FN-4057-SCD-FN-4057-S2026-05-11
00840124525634FibFixCD-FN-4037CD-FN-40372026-05-11
00840124525641FibFixCD-FN-4047CD-FN-40472026-05-11
00840124525658FibFixCD-FN-4057CD-FN-40572026-05-11
00840124521407Metalogix9003179003172025-09-30
00840124521414Metalogix9003209003202025-09-30
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525573FuzeFix LargeTN-FT-7070TN-FT-70702026-04-23
00840124525580FuzeFix LargeTN-FT-7024TN-FT-70242026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00819034022557TalarLift STS CD-TL-5050CD-TL-50502019-04-29
00840124525535Metalogix RevolutionTN-TR-0092TN-TR-00922026-04-17
00840124516113FibFixFN-SS-4014FN-SS-40142026-04-09
00840124516120FibFixFN-SS-40162026-04-09
00840124516137FibFixFN-SS-4018FN-SS-40182026-04-09
00840124516144FibFixFN-SS-4020FN-SS-40202026-04-09

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