FDA.reportPublic FDA data

Apollo

Primary DI
B048XTS55151
Brand
Apollo
Company
MEDLINE INDUSTRIES, INC.
Model
01
Device description
Apollo XT Suture Anchor Delivery System, PEEK Screw, 5.5 x 15mm, Three #2 ForceBraid™ Sutures
Published
2015-10-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K142230000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142230000Apollo Suture Anchor System and Titan ScrewsValeris Medical2014-09-10MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B048XTS55152PackageHIBCC5In Commercial Distribution
B048XTS55151PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196321445MEDLINEMDS30804MDS308042026-09-24
30080196293548MEDLINENON28625NON286252026-09-24
40080196921554GeminiGEM5172GEM51722016-10-14
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10080196632381MEDLINE INDUSTRIES, INC.MSC7344EPMSC7344EP2021-05-18
10193489104516MEDLINEMRPP2910MRPP29102024-07-11
10884389931943MEDLINE INDUSTRIES, INC.MSC7318EPMSC7318EP2021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196184085GeminiGEM3118SGEM3118S2016-10-14
20080196184283GeminiGEM3130SGEM3130S2016-10-14
20080196184344GeminiGEM3136SGEM3136S2016-10-14
20080196184498GeminiGEM3140SGEM3140S2016-10-14
20080196184559GeminiGEM3145SGEM3145S2016-10-14
20080196184610GeminiGEM3148SGEM3148S2016-10-14
20080196184696GeminiGEM3154SGEM3154S2016-10-14
20080196184986GeminiGEM4118SGEM4118S2020-12-22
20080196921185GeminiGEM1148GEM11482016-10-14
20080196921192GeminiGEM1154GEM11542016-10-14
20080196921307GeminiGEM3118GEM31182016-10-14
20080196921321GeminiGEM3124GEM31242016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810146164517RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164531RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164562RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164579RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164623RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164654RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164685RedifixTRAX SURGICAL INC.MBI2026-07-20
00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
00860016070004ICONN Revolution 6.5MM Knotless Suture AnchorICONN ORTHOPEDICS LLCMBI2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant SystemT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and InserterT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, LongT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462928VersiTILT Button, 2.4x12mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XLT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2026-07-16