NA

Primary DI
H980400668E0
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
400.668E
Catalog number
400668E
Device description
1.7MM TI EMERGENCY SCREW WITH FLUTED TIP 18MM
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
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQNExternal Mandibular Fixator And/Or DistractorDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953806000SYNTHES (USA) MIDFACIAL SYSTEMSynthes (Usa)1996-03-08JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587044873PrimaryGS10
H980400668E0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758704487310887587044873

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-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). Screws available are: 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. This device must be sterilized prior to use.

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
false
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
00888118154910LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154927LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154934LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118154965LEVEL ONE CMF, STERILEKLS-Martin L.P.MQN2026-10-21
10888118154979LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
10888118154986LEVEL ONE CMFKLS-Martin L.P.MQN2026-10-21
00888118128638LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128645LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128652LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128669LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128676LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118128683LEVEL ONE CMFKLS-Martin L.P.MQN2020-08-24
00888118112682LEVEL ONE CMFKLS-Martin L.P.MQN2018-01-26
00888118113399DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113405DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113412DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113429DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113436DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118113443DISTRACTION, INTERNALKLS-Martin L.P.MQN2018-01-26
00888118108685LEVEL ONE CMFKLS-Martin L.P.MQN2017-08-17
00888118107800LEVEL ONE CMFKLS-Martin L.P.MQN2017-03-31
00888118107817LEVEL ONE CMFKLS-Martin L.P.MQN2017-03-31
00888118104007DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104014DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104021DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104038DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104045DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118104052DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118105431DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16
00888118105554DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.MQN2016-12-16