FDA.reportPublic FDA data

LSI Arthroereisis Peg

Primary DI
00819034029402
Brand
LSI Arthroereisis Peg
Company
FUSION ORTHOPEDICS, LLC
Model
TN-LD-6001
Catalog number
TN-LD-6001
Device description
(not in use)
Published
2020-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MJWProsthesis, Subtalar, Plug, Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJWProsthesis, Subtalar, Plug, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922292000LUNDEEN SUBTALAR PEG IMPLANTSgarlato Laboratories, Inc.1992-10-23MJW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819034029402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819034029402008190340294028190340294020819034029402

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It 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 at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124519459LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519466LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519473LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519480LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519497LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519503LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519510LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519527LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519534LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519541LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519558LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519565LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-15
00840124519428LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-14
00840124519435LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-14
00840124519442LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2025-05-14
00819034029433LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029440LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029457LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029464LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029471LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029488LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029495LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029501LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029518LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029525LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029532LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029549LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029556LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-24
00819034029303LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-20
00819034029310LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-20