FDA.reportPublic FDA data

OIC Suture Anchor System

Primary DI
10811998038794
Brand
OIC Suture Anchor System
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
01-SA04
Device description
5.5MM TAP
Published
2021-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K182736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182736000OIC Suture Anchor SystemThe Orthopaedic Implant Company2018-12-28MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811998038794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081199803879410811998038794

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
775 636 8281Info@OrthoImplantCompany.com

Regulatory Flags#

DUNS number
070061160
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811998032150OIC Cannulated Screw System01-SHS102018-07-31
10811998036301OIC Intramedullary Nail System01-IM302018-07-31
10811998036325OIC Intramedullary Nail System01-IM322018-07-31
10811998036349OIC Intramedullary Nail System01-IM342018-07-31
10811998036387OIC Intramedullary Nail System01-IM402018-07-31
10811998036394OIC Intramedullary Nail System01-IM412018-07-31
10811998036561OIC Intramedullary Nail System01-IM582018-08-07
10811998038022OIC Intramedullary Nail System01-IMSE032018-08-07
10811998038039OIC Intramedullary Nail System01-IMSE042018-08-07
M69601IM300OIC Intramedullary Nail System01-IM302017-02-01
M69601IM320OIC Intramedullary Nail System01-IM322017-02-01
M69601IM340OIC Intramedullary Nail System01-IM342017-02-01
M69601IM400OIC Intramedullary Nail System01-IM402017-02-01
M69601IM410OIC Intramedullary Nail System01-IM412017-02-01
M69601SHS100OIC Cannulated Screw System01-SHS102017-02-01
10811998039845OIC Variable Angle Small Fragment Locking Plate SystemPHP-09172L2024-09-06
10811998039852OIC Variable Angle Small Fragment Locking Plate SystemPHP-09172R2024-09-06
10811998031924OIC Variable Angle Small Fragment Locking Plate System01-SF282024-06-20
10811998030224OIC Cannulated Screw System07-0362024-06-05
10811998030248OIC Cannulated Screw System13-0662024-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277405609LigaMend™ (Black)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405616LigaMend™ (Blue)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405623LigaMend™RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405630Strut SutureRIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405715LigaMend™ Soft Button (Black)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405722LigaMend™ Soft Button (Blue)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277411358No-Tie ButtonRIVERPOINT MEDICAL, LLCMBI2026-03-19
10888867550817Arthrex®ARTHREX, INC.MBI2026-03-12
00888867550827Arthrex®ARTHREX, INC.MBI2026-03-12
00860013967000RapidFix™ All-Suture Dual AnchorSuture Tech, Inc.MBI2026-03-09
00888867569638Arthrex®ARTHREX, INC.MBI2026-03-04
00888867569645Arthrex®ARTHREX, INC.MBI2026-03-04
00888867569652Arthrex®ARTHREX, INC.MBI2026-03-04
00888867573130Arthrex®ARTHREX, INC.MBI2026-03-04
00812444029673OrthoButton ALRIVERPOINT MEDICAL, LLCMBI2026-03-03
00889024706323Jgrknt Large 2.9mm Reusable TrocarZimmer, Inc.MBI2026-02-23
00889024706330Jgrknt Large 2.9mm Reusable GuideZimmer, Inc.MBI2026-02-23
00888867470149Arthrex®ARTHREX, INC.MBI2026-02-08
00888867470170Arthrex®ARTHREX, INC.MBI2026-02-08
00888867593138Arthrex®ARTHREX, INC.MBI2026-02-08
30653405546508Y-KnotlessTM FlexConmed CorporationMBI2026-02-06
30653405990721Y-KnotlessTM FlexConmed CorporationMBI2026-02-06
00810155330989Tigon MedicalTigon Medical LLCMBI2026-02-04
00810155331214Tigon MedicalTigon Medical LLCMBI2026-02-04
00810155331276Tigon MedicalTigon Medical LLCMBI2026-01-23
00888867520745Arthrex®ARTHREX, INC.MBI2026-01-21
08903993499856AUXILOCK PEEK OPTIMA Screw-In Suture AnchorAuxein Medical Private LimitedMBI2026-01-20
28437019739748QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
28437019739755QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
28437019739762QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14