FDA.report

Arthrex®

Primary DI
00888867367296
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1665KPSL
Catalog number
AR-1665KPSL
Device description
LNT Imp. System, 4.75 PEEK KL SwiveLock
Published
2021-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MAIFastener, fixation, biodegradable, soft tissue
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications

CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867367296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867367296008888673672968888673672960888867367296

GMDN Terms

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

Contacts

PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags

DUNS number
131747628
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

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00888867529045Arthrex®AR-8827H-12AR-8827H-122026-03-16
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