FDA.reportPublic FDA data

VERSALOK ORTHOCORD

Primary DI
10886705001224
Brand
VERSALOK ORTHOCORD
Company
Medos International Sàrl
Model
210808
Catalog number
210808
Device description
VERSALOK ANCHOR w/ORTHOCORD PEEK & Titanium Anchor (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm)
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
GASSuture, nonabsorbable, synthetic, polyester
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
HWCScrew, fixation, bone
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
NEWSUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2
GASSuture, Nonabsorbable, Synthetic, PolyesterGeneral, Plastic Surgery2
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2
HWCScrew, Fixation, BoneOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2
NEWSuture, Surgical, Absorbable, PolydioxanoneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063478000VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810)Depuy Mitek, A Johnson & Johnson Company2006-12-15HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705001224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500122410886705001224

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature026 Degrees Celsius
Handling Environment Temperature080 Degrees Fahrenheit
Storage Environment Temperature026 Degrees Celsius
Storage Environment Temperature080 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04

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Primary DI, Brand, Company table
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