FDA.reportPublic FDA data

LSI Arthroereisis Peg

Primary DI
00819034029327
Brand
LSI Arthroereisis Peg
Company
FUSION ORTHOPEDICS, LLC
Model
TN-LD-4001
Catalog number
TN-LD-4001
Device description
Starter Awl Left
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
00819034029327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819034029327008190340293278190340293270819034029327

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
00840124516779FibFixTN-FN-9000TN-FN-90002026-04-09
00840124517783FibFixTN-FN-9000-STN-FN-9000-S2026-04-09
00840124521773PolyLock MidfootTN-CA-2501TN-CA-25012025-10-02
00840124521780PolyLock MidfootTN-CA-2004TN-CA-20042025-10-02
00840124521797PolyLock MidfootTN-CA-2003TN-CA-20032025-10-02
00840124521803PolyLock MidfootTN-CA-2002TN-CA-20022025-10-02
00840124521810PolyLock MidfootTN-CA-2001TN-CA-20012025-10-02
00840124521827PolyLock MidfootTN-CA-2503TN-CA-25032025-10-02
00840124521834PolyLock MidfootTN-CA-2502TN-CA-25022025-10-02
00840124521841PolyLock MidfootTN-CA-2504TN-CA-25042025-10-02
00840124525467FibFixTN-FN-9000-ATN-FN-9000-A2026-04-09
00840124525542FibFixTN-FN-9908TN-FN-99082026-04-23
00840124525559FibFixTN-FN-9912TN-FN-99122026-04-23
00840124525566FuzeFix LargeTN-FT-7096TN-FT-70962026-04-23
00840124525597FuzeFix LargeTN-FT-7050TN-FT-70502026-04-23
00840124519220IntraLockTN-LL-5861TN-LL-58612025-05-14
00840124519244LapiLockTN-LL-5075TN-LL-50752025-05-14
00840124519251LapiLockTN-LL-5085TN-LL-50852025-05-14
00840124519268LapiLockTN-LL-5185TN-LL-51852025-05-14
00840124519275LapiLockTN-LL-5285TN-LL-52852025-05-14

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