FDA.reportPublic FDA data

Signature™ Instruments

Primary DI
70880304927499
Brand
Signature™ Instruments
Company
Biomet Orthopedics, LLC
Model
42-422411
Catalog number
42-422411
Published
2022-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOGKnee arthroplasty implantation system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868507113PrimaryGS10
70880304927499Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868507113008878685071138878685071130887868507113
7088030492749970880304927499

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
2
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL000191I00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001B2750PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001B4030PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001B46I0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001BB6K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001BDK40PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001I84D0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001I9130PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001I9D80PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001IB6D0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001III50PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
TKRL0001IL240PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2026-03-03
00889024704442Vanguard XP® Complete Knee SystemBiomet Orthopedics, LLCOOG2025-12-23
00840097515151iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515168iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515175iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515182iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515199iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
00840097515205iTotal Identity 3DP Porous KneeRestor3d, Inc.OOG2025-12-02
07630345783677My Knee Bone ModelsMedacta International SAOOG2025-07-03
TKRL000144II0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL0001494K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL00014KL00PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL00014L0K0PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000151910PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000151F5PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000152B8PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000153830PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL000155150PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18
TKRL00015694PointCloud Knee InstrumentsUnik Orthopedics Inc.OOG2025-06-18