FDA.reportPublic FDA data

3.2MM X 410MM COCR THD TIP

Primary DI
00887868096365
Brand
3.2MM X 410MM COCR THD TIP
Company
Biomet Orthopedics, LLC
Model
14-443054
Catalog number
14-443054
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HTYPIN, FIXATION, SMOOTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063570000
K831005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063570000BIOMET TIBIAL LOCKING NAIL SYSTEMBiomet Manufacturing Corp2007-02-27HSB
K831005000WIRE & STEINMAN PINSKirschner Medical Corp.1983-05-18HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868096365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868096365008878680963658878680963650887868096365

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07630894830891APTUSMedartis AGHTY2026-06-01
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHHTY2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHHTY2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHHTY2025-10-01
07630037863977APTUSMedartis AGHTY2025-07-31
07630037863984APTUSMedartis AGHTY2025-07-31
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
07613327084191STEINMANNStryker GmbHHTY2025-01-09
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2024-09-19
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07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHHTY2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202327Drill S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
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