FDA.reportPublic FDA data

Pusher 3 Leg 14x12

Primary DI
M209183120
Brand
Pusher 3 Leg 14x12
Company
BIOPRO, INC.
Model
18312
Published
2019-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072298000BIOPRO MEMORY STAPLE, MODELS 18062-18073Biopro, Inc.2007-10-29JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209183120PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100124843502.5 x 19mm HBS Screw195542021-06-14
00810012485852Horizon Subtalar Gen 2 - 11mm Implant226472019-06-12
00810012483797DRILL GUIDE 15 18MM176502019-06-10
00810012484183MEASURING SLEEVE186582019-06-06
00810012485364MPJ TRIAL 20mm (MD)122362019-06-06
00810012484879HBS SCREW 3.0 X 16MM SDST205192019-06-05
00810012481830GOEZ SCREW 4.0 X 50MM190502019-06-04
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20918608010mm HBS® Standard Compression186082015-09-16
M20918609011mm HBS® Standard Compression186092015-09-16
M20918610012mm HBS® Standard Compression186102015-09-16
M20918611013mm HBS® Standard Compression186112015-09-16
M20918612014mm HBS® Standard Compression186122015-09-16
M20918613015mm HBS® Standard Compression186132015-09-16
M20918614016mm HBS® Standard Compression186142015-09-16
M20918615017mm HBS® Standard Compression186152015-09-16
M20918616018mm HBS® Standard Compression186162015-09-16
M20918617019mm HBS® Standard Compression186172015-09-16
M20918618020mm HBS® Standard Compression186182015-09-16

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00840314263421gSourceGSOURCE LLCLXH2026-07-24
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00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
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07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
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00850075111121NativeINS ORTHO INC.LXH2026-07-22
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