FDA.reportPublic FDA data

Precision MIS Bunion System

Primary DI
00889795132611
Brand
Precision MIS Bunion System
Company
Paragon 28, Inc.
Model
P27-190-TL40
Catalog number
P27-190-TL40
Device description
Ø4.0 Driver, Cannulated Long
Published
2024-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190586000
K241262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190586000Monster® Screw SystemParagon 28, Inc.2019-04-03HWC
K241262000Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.2024-06-05HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795132611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795132611008897951326118897951326110889795132611

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042961576
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795154507Spider Monkey Bone Transport SystemP38-300-2810P38-300-28102026-06-10
00889795154514Spider Monkey Bone Transport SystemP38-300-2410P38-300-24102026-06-10
00889795154521Spider Monkey Bone Transport SystemP38-300-3210P38-300-32102026-06-10
00889795154538Spider Monkey Bone Transport SystemP38-900-0001P38-900-00012026-06-10
00889795154545Spider Monkey Bone Transport SystemP38-900-0002P38-900-00022026-06-10
00889795154552Spider Monkey Bone Transport SystemP38-910-0001P38-910-00012026-06-10
00889795154569Spider Monkey Bone Transport SystemP38-910-0002P38-910-00022026-06-10
00889795154576Spider Monkey Bone Transport SystemP38-910-0003P38-910-00032026-06-10
00889795154583Spider Monkey Bone Transport SystemP38-900-BONBP38-900-BONB2026-06-10
00889795154590Spider Monkey Bone Transport SystemP38-900-BONLP38-900-BONL2026-06-10
00889795154606Spider Monkey Bone Transport SystemP38-300-4016P38-300-40162026-06-10
00889795154613Spider Monkey Bone Transport SystemP38-900-0003P38-900-00032026-06-10
00889795154620Spider Monkey Bone Transport SystemP38-210-320BP38-210-320B2026-06-10
00889795154637Spider Monkey Bone Transport SystemP38-210-420BP38-210-420B2026-06-10
00889795154644Spider Monkey Bone Transport SystemP38-211-320BP38-211-320B2026-06-10
00889795154651Spider Monkey Bone Transport SystemP38-211-420BP38-211-420B2026-06-10
00889795038562Small Bone Phantom Intramedullary Nail SystemP30-196-2323P30-196-23232019-10-17
00889795118011Monkey Rings™ External Fixation SystemP45-511-0001P45-511-00012026-05-06
00889795152114Monkey Rings™ External Fixation SystemP45-113-0120P45-113-01202026-05-06
00889795152121Monkey Rings™ External Fixation SystemP45-113-0140P45-113-01402026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906309EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906316EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906323EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556901946EVOSSmith & Nephew, Inc.HWC2026-06-24
00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586416CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586454CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586478CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586690CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586706CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586713CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586720CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586737CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10