FDA.reportPublic FDA data

ALLTHREAD KNOTLESS PEEK-OPTIMA

Primary DI
00880304476639
Brand
ALLTHREAD KNOTLESS PEEK-OPTIMA
Company
Biomet Sports Medicine, LLC
Model
904840P
Catalog number
904840P
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
JDRSTAPLE, FIXATION, BONE
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060693000
K070389000
K080088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060693000MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHORArthrotek, Inc.2006-06-06HWC
K070389000PEEK KNOTLESS ANCHORSBiomet Sports Medicine, Inc.2007-08-09HWC
K080088000BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSBiomet Manufacturing, Inc.2008-06-11HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304476639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304476639008803044766398803044766390880304476639

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
627100159
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304000674MINI HARPOON9029229029222015-10-24
00880304001145HARPOON9029209029202015-10-24
00880304002586TITANIUM INTERFERENCE SCREW9068919068912015-10-24
00880304002821HARPOON9029299029292015-10-24
00880304007048BIO-PHASE II9055029055022015-10-24
00880304008298TI SCREW ES9025549025542015-10-24
00880304008434TI SCREW ES9025569025562015-10-24
00880304009028TITANIUM INTERFERENCE SCREW9096949096942015-10-24
00880304011168TITANIUM INTERFERENCE SCREW9068929068922015-10-24
00880304011175TITANIUM INTERFERENCE SCREW9096489096482015-10-24
00880304116511BONE MULCHCP550800CP5508002015-10-24
00880304117303TITANIUM INTERFERENCE SCREWCP909580CP9095802015-10-24
00880304117310TITANIUM INTERFERENCE SCREWCP909581CP9095812015-10-24
00880304117358TITANIUM INTERFERENCE SCREWCP909585CP9095852015-10-24
00880304404663MINI HARPOON9029239029232015-10-24
00880304405363POLY SUTURE BUTTON9042159042152015-10-24
00880304405387POLY SUTURE BUTTON9042199042192015-10-24
00880304405974NO-PROFILE9045309045302015-10-24
00880304405981NO-PROFILE9045359045352015-10-24
00880304405998NO-PROFILE9045409045402015-10-24

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