FDA.reportPublic FDA data

NA

Primary DI
10705034790954
Brand
NA
Company
Synthes GmbH
Model
498.525
Catalog number
498525
Device description
5.0MM TI SIDE-OPENING SCREW 25MM
Published
2015-09-14
Public version status
Update
Distribution status
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930891000SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYSTSynthes (Usa)1994-04-29KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034790954PrimaryGS10
H9814985250SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503479095410705034790954

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.KWP2026-10-22
00840019978156Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978163Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978170Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978187Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978194Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978200Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978217Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978224Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978231Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978248Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978255Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978262Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978279Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978286Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978293Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978309Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978316Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978323Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978330Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978347Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978354Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978361Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978378Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978385Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978392Reform TiPRECISION SPINE, INC.KWP2026-10-19