FDA.reportPublic FDA data

NA

Primary DI
10887587055893
Brand
NA
Company
SYNTHES (U.S.A.) LP
Model
487.975
Catalog number
487975
Device description
TI SINGLE VECTOR DISTRACTOR PROXIMAL FOOT/LEFT
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
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
K981075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981075000SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEETSynthes (Usa)1998-06-22MQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587055893PrimaryGS10
H9804879750SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758705589310887587055893

GMDN Terms#

Term, Definition table
TermDefinition
Implantable craniofacial bone distractorAn implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.

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
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
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118108685LEVEL ONE CMFKLS-Martin L.P.MQN2017-08-17
00888118006189LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118006202LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118006226LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118007261LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118007278LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118032812LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037480LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037503LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118037510LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118039439LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118039446LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044457LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044471LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044495LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044518LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044532LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044556LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044631LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044655LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118044679LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045010LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045034LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045058LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045072LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045096LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045119LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045133LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045195LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24
00888118045485LEVEL ONE CMFKLS-Martin L.P.MQN2016-03-24