FDA.reportPublic FDA data

RIGIDFIX BIOCRYL

Primary DI
10886705001309
Brand
RIGIDFIX BIOCRYL
Company
Medos International Sàrl
Model
210816
Catalog number
210816
Device description
"RIGIDFIX BIOCRYL FEMORAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm BIOCRYL (TCP/PLA), (2) each Sleeve Assemblies, and (1) each Interlocking Trocar"
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH
HWCScrew, fixation, bone
JDRStaple, fixation, bone
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDRStaple, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090669000
K091041000
K150209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090669000RIGIDFIX BIOCRYL CROSS PIN KITSDepuy Mitek, A Johnson & Johnson Company2009-04-03MAI
K091041000RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITSDepuy Mitek, A Johnson & Johnson Company2009-08-07MAI
K150209000Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop AncDepuy Mitek, A Johnson and Johnson Company2015-10-06MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705001309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500130910886705001309

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03700569668006NANEWCLIP TECHNICSHWC2026-11-05
03700569668013NANEWCLIP TECHNICSHWC2026-11-05
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