FDA.reportPublic FDA data

OIC Suture Anchor System

Primary DI
10811998038817
Brand
OIC Suture Anchor System
Company
ORTHOPAEDIC IMPLANT COMPANY, THE
Model
SA-5515V
Device description
SUTURE ANCHOR, 5.5MM x 15MM
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
true

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
10811998038817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081199803881710811998038817

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)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Millimeter
Outer Diameter5Millimeter

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

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Primary DI, Brand, Company table
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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
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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
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00810155330989Tigon MedicalTigon Medical LLCMBI2026-02-04
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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