FDA.reportPublic FDA data

NA

Primary DI
10705034779553
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
411.400
Catalog number
411400
Device description
4.0MM TI CANCELLOUS BONE SCREW SELF-TAPPING/FIXED ANGLE 12MM
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033844000SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEMSynthes (Usa)2004-02-05KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034779553PrimaryGS10
H98141140000SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503477955310705034779553

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982249210NA60.550.040605500402017-02-20
10886982239884NA530.4125304122016-12-31
10886982192172NA329.7223297222017-02-20
10886982192295LC-DCP329.9183299182017-02-20
10886982201461NA398.56398562017-02-20
10886982201478NA398.58398582017-02-20
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.KWQ2026-10-01
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10888857598263Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
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10888857598287Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598409Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598416Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598423Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598430Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598447Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598454Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598461Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598478Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598485Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598492Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598508Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598515Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598522Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24