FDA.report

Small Bone Phantom Intramedullary Nail System

Primary DI
00889795052780
Company
PARAGON 28, INC.
Model
P30-L2-5554
Catalog number
P30-L2-5554
Device description
Lapidus Nail, 3-Hole, Left, 54mm
Published
2019-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
042961576
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00889795052780PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00889795052780PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component2Orthopedic888.3030YEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Arthrodesis nail, non-sterileA non-sterile rod made of metal or other material (e.g., carbon fibre) designed to be inserted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] to immobilize by holding the ends of a fractured or diseased bone together (i.e., in position) for the purpose of joint fusion or arthrodesis (an operation to permanently fix a joint in position). The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device intended to be sterilized prior to use.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

No records found.

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00848665031812LID, 3.5mm SCREW CADDYADVANCED ORTHOPAEDIC SOLUTIONS, INC.KTW2022-06-06
H679439200NASYNTHES (U.S.A.) LPKTW2018-07-18
H6792411850LCPSYNTHES (U.S.A.) LPKTW2015-09-14
H6792411880LCPSYNTHES (U.S.A.) LPKTW2015-09-14
H679437200NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437220NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437240NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437260NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437500NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437520NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437540NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437560NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437700NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437720NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437740NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437760NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437900NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437920NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437940NASYNTHES (U.S.A.) LPKTW2015-09-14
H679437960NASYNTHES (U.S.A.) LPKTW2015-09-14
H679438960NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439210NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439220NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439230NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439240NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439250NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439280NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439320NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439430NASYNTHES (U.S.A.) LPKTW2015-09-14
H679439470NASYNTHES (U.S.A.) LPKTW2015-09-14