FDA.report

IntraLock

Primary DI
00840124519183
Brand
IntraLock
Company
FUSION ORTHOPEDICS, LLC
Model
TN-LL-7920
Catalog number
TN-LL-7920
Device description
2.0mm Drill Guide Fenestration
Published
2025-05-14
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
false

Related Records

Product Codes

CodeName
JDRStaple, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840124519183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124519183008401245191838401245191830840124519183

GMDN Terms

TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080307067
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840124525382FuzeFix Max FTFX-FT-2534-SFX-FT-2534-S2026-02-17
00840124525399FuzeFix Max FTFX-FT-2536-SFX-FT-2536-S2026-02-17
00840124525405FuzeFix Max FTFX-FT-2538-SFX-FT-2538-S2026-02-17
00840124525412FuzeFix Max FTFX-FT-2542-SFX-FT-2542-S2026-02-17
00840124525429FuzeFix Max FTFX-FT-2544-SFX-FT-2544-S2026-02-17
00840124525436FuzeFix Max FTFX-FT-2546-SFX-FT-2546-S2026-02-17
00840124525443FuzeFix Max FTFX-FT-2548-SFX-FT-2548-S2026-02-17
00840124525320FuzeFix MiniTN-FX-6012TN-FX-60122026-02-03
00840124525337FuzeFix MiniTN-FX-6013TN-FX-60132026-02-03
00840124525344Metalogix RevolutionTN-TR-0095TN-TR-00952026-02-03
00840124525351Metalogix RevolutionTN-TR-0094TN-TR-00942026-02-03
00840124525368Metalogix RevolutionTN-TR-0090TN-TR-00902026-02-03
00840124525245FuzeFix MiniTN-FX-6011TN-FX-60112026-01-22
00840124525252Metalogix RevolutionTN-TR-0091TN-TR-00912026-01-22
00840124525269Metalogix RevolutionMX-RP-0120MX-RP-01202026-01-22
00840124525276Metalogix RevolutionMX-RP-0140MX-RP-01402026-01-22

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