FDA.reportPublic FDA data

LSI Arthroereisis Peg

Primary DI
00819034029433
Brand
LSI Arthroereisis Peg
Company
FUSION ORTHOPEDICS, LLC
Model
CD-LD-7000
Catalog number
CD-LD-7000
Device description
LSI Drill 4.9 mm
Published
2020-11-24
Public version status
New
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
00819034029433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819034029433008190340294338190340294330819034029433

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-use, non-sterileA non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use 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
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
00819034029327LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCMJW2020-11-20