FDA.reportPublic FDA data

ICONN Campbell PEEK Interference Screw - 6MM x 20MM

Primary DI
00860419000288
Brand
ICONN Campbell PEEK Interference Screw - 6MM x 20MM
Company
ICONN ORTHOPEDICS LLC
Model
610620
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180670000ICONN Campbell Interference ScrewIconn Orthopedics, LLC2018-12-07HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860419000285PackageGS14In Commercial Distribution
00860419000288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086041900028510860419000285
00860419000288008604190002888604190002880860419000288

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
055774745
Device count
1
Lot or batch
true
Serial number
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
00860006776015ICONN Revolution Knotless Suture Anchor3550002025-09-17
00860006776022ICONN Square Suture Anchor Knotless125000K2025-09-17
00860419000226ICONN Square 2.5MM Suture Anchor1250002025-09-17
00860419000257ICONN Answer II 4.75MM Suture Anchor1475012025-09-17
00860419000264ICONN Answer II 5.5MM Suture Anchor1550012025-09-17
00860419000271ICONN Answer II 6.5MM Suture Anchor1650012025-09-17
00860419000295ICONN Revolution Knotless Suture Anchor3500002025-09-17
00860419000202ICONN Answer 4.75MM Suture Anchor1475001475002015-09-23
00860419000219ICONN Answer 5.5MM Suture Anchor1550001550002015-09-23

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Primary DI, Brand, Company table
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