FDA.report

Baby Gorilla®/Gorilla® Plating System

Primary DI
00889795054210
Company
PARAGON 28, INC.
Model
P51-981-510L
Catalog number
P51-981-510L
Device description
Precision Guide, Subtalar Joint, Guide Arm, Left
Published
2020-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
042961576
Device count
1
DM exempt
false
Premarket exempt
true
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
00889795054210PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00889795054210PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FZXGuide, Surgical, Instrument1General, Plastic Surgery878.4800NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

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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