FDA.report

Titan

Primary DI
B048IS10300
Brand
Titan
Company
VALERIS MEDICAL LLC
Model
01
Device description
Titan Interference Screw, PEEK, 10 x 30mm
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications

CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B048IS10300PrimaryHIBCC0

GMDN Terms

TermDefinition
Ligament bone anchorA non-bioabsorbable device designed to be implanted into bone specifically to attach the ends of a ligament (synthetic or natural source) to the bone, e.g., during reconstructive knee surgery. The 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

Regulatory Flags

DUNS number
079444554
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10818614021369Apollo27-111552020-08-07
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00818614021508BoneCam08-325292020-08-04
00818614021515BoneCam08-325332020-08-04
00818614021522BoneCam08-325262020-08-04
00818614021539BoneCam08-325272020-08-04
00818614021546BoneCam08-325302020-08-04
00818614021553BoneCam08-325312020-08-04
00818614021577Apollo01-45P2020-08-04
00818614021584Apollo01-55P2020-08-04
00818614021591Apollo01-65P2020-08-04
00818614021607Apollo01-45T2020-08-04
00818614021614Apollo01-55T2020-08-04
00818614021621Apollo01-65T2020-08-04
B048LA45200Apollo012015-10-15

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