FDA.reportPublic FDA data

Grappler® Suture Anchor System

Primary DI
00889795154804
Brand
Grappler® Suture Anchor System
Company
Paragon 28, Inc.
Model
P63-001-3510-SK
Catalog number
P63-001-3510-SK
Device description
3.5 x 10mm Knotless Anchor - SK
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K262047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262047000Grappler Suture Anchor SystemParagon 28, Inc.2026-08-03MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795154804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795154804008897951548048897951548040889795154804

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795154811Grappler® Suture Anchor SystemP63-001-4515-SKP63-001-4515-SK2026-11-04
00889795154828Grappler® Suture Anchor SystemP63-001-5515-SKP63-001-5515-SK2026-11-04
00889795150073APEX 3D Total Ankle Replacement SystemP11-700-TEMPP11-700-TEMP2026-10-12
00889795150080APEX 3D Total Ankle Replacement SystemP11-710-TUF1P11-710-TUF12026-10-12
00889795150097APEX 3D Total Ankle Replacement SystemP11-710-TUF2P11-710-TUF22026-10-12
00889795150103APEX 3D Total Ankle Replacement SystemP11-710-TUF3P11-710-TUF32026-10-12
00889795150110APEX 3D Total Ankle Replacement SystemP11-710-TUF4P11-710-TUF42026-10-12
00889795150127APEX 3D Total Ankle Replacement SystemP11-710-TUF5P11-710-TUF52026-10-12
00889795150134APEX 3D Total Ankle Replacement SystemP11-710-TUF6P11-710-TUF62026-10-12
00889795150141APEX 3D Total Ankle Replacement SystemP11-754-CS12P11-754-CS122026-10-12
00889795150158APEX 3D Total Ankle Replacement SystemP11-754-CT12P11-754-CT122026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemP11-754-CS14P11-754-CS142026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemP11-754-CT14P11-754-CT142026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemP11-754-CS16P11-754-CS162026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemP11-754-CT16P11-754-CT162026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemP11-754-DS12P11-754-DS122026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemP11-754-DT12P11-754-DT122026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemP11-754-DS14P11-754-DS142026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemP11-754-DT14P11-754-DT142026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemP11-754-DS16P11-754-DS162026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795154811Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
00889795154828Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
09353903030331OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
00888867576032Arthrex®ARTHREX, INC.MBI2026-10-20
00888867576056Arthrex®ARTHREX, INC.MBI2026-10-20
00888867627840Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627857Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MBI2026-10-07
00817337000586Integrity Retractable Implant InserterAnika Therapeutics, Inc.MBI2026-10-05
20845854655501Argo KnotlessConmed CorporationMBI2026-09-25
20845854655518Argo KnotlessConmed CorporationMBI2026-09-25
00889024711280Jgrknt Reusable Fishmouth Perc GuideBiomet Orthopedics, LLCMBI2026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideBiomet Orthopedics, LLCMBI2026-08-25
00810198920178TeKBraceTheraMicro, LLCMBI2026-08-14
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCMBI2026-07-31
00810146164340RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164357RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164388RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164418RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164449RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164456RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164463RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164500RedifixTRAX SURGICAL INC.MBI2026-07-20