FDA.reportPublic FDA data

NA

Primary DI
10886982362377
Brand
NA
Company
Synthes GmbH
Model
SD03.211.458
Catalog number
SD03211458
Device description
AIMING ARM SCREW TARGETING CLAMP
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982362377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698236237710886982362377

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic ball spikeA hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034712307NA03.604.002036040022016-12-31
10705034712802NA03.606.011036060112016-12-31
10705034714592NA03.613.012036130122016-12-31
10705034767819VentroFix304.8343048342016-12-31
10705034768939NA314.0643140642016-12-31
10705034768960Click'X314.0673140672016-12-31
10705034768977Click'X314.0683140682016-12-31
10705034768984Click'X314.0693140692016-12-31
10705034769646NA328.0263280262016-12-31
10705034772608NA388.3643883642016-12-31
10705034775401NA389.2883892882016-12-31
10705034777375NA394.5853945852016-12-31
20705034764051NA292.0202920202019-08-29
00863176000317FIBULINKFGS-1100FGS11002020-03-26
00863176000324FIBULINKFGS-1300FGS13002020-03-26
00863176000300FIBULINKFGS-1000FGS10002017-06-08
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079PDG2000Advantage-C Ti3D, Cervical InterbodyIntelivation, LLCFZX2026-07-10
M697X07901121Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.FZX2026-07-08
00190446948063Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948186Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
09421038412237KA Femoral Alignment GuideENZTEC LIMITEDFZX2026-06-24
09421038412244KA Femoral Alignment Guide - Medial PaddleENZTEC LIMITEDFZX2026-06-24
09421038412251KA Femoral Alignment Guide - Lateral PaddleENZTEC LIMITEDFZX2026-06-24
09421038412268KA Femoral Alignment Guide - FanENZTEC LIMITEDFZX2026-06-24
09421038412275KA Femoral Alignment Guide – IM GuideENZTEC LIMITEDFZX2026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide ConnectorENZTEC LIMITEDFZX2026-06-24
03700879518701NANOVASTEPFZX2026-06-23
03700879518718NANOVASTEPFZX2026-06-23
03700879518725NANOVASTEPFZX2026-06-23
03700879518732NANOVASTEPFZX2026-06-23
08800089483440Surgical InstrumentJeil Medical CorporationFZX2026-06-10
08800089483464Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2026-06-10
008401944960013P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944960183P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962543P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944962613P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971763P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971833P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944971903P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
008401944972063P Small-Mini Frag SystemORTHOPEDIATRICS CORP.FZX2026-06-10
00889024701526Identity® Shoulder SystemZimmer, Inc.FZX2026-06-10
00889795154538Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154545Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10
00889795154613Spider Monkey Bone Transport SystemParagon 28, Inc.FZX2026-06-10