FDA.reportPublic FDA data

NA

Primary DI
H679450873S0
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
450.873S
Catalog number
450873S
Device description
6.0MM TI LOCKING SCREW 30MM- F/DISTAL FEMORAL NAILS-STERILE
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970733000SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEMSynthes (Usa)1997-04-02HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982226365PrimaryGS10
H679450873S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698222636510886982226365

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
M791TPK1237HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
M791TPK1253HTA0Traction Pin KitBIOACCESS INCHTY2026-09-04
00840536824974PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824981PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825025PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22