FDA.reportPublic FDA data

LSI Arthroereisis Peg

Primary DI
00819034029310
Brand
LSI Arthroereisis Peg
Company
FUSION ORTHOPEDICS, LLC
Model
TN-LD-2000
Catalog number
TN-LD-2000
Device description
Angled Awl 45 Degree
Published
2020-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00819034029310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819034029310008190340293108190340293100819034029310

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). 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

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
00819034029327LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-20