FDA.reportPublic FDA data

MAXFRAME

Primary DI
10886982338587
Brand
MAXFRAME
Company
SYNTHES (U.S.A.) LP
Model
1100010-01
Catalog number
110001001
Device description
MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - MEDIUM
Published
2022-04-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
OSNSoftware for diagnosis/treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
OSNSoftware For Diagnosis/TreatmentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982338587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698233858710886982338587

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive, non-powered structural component of an external orthopaedic fixation system intended for bone/joint treatment (typically fracture stabilization, deformity correction, or distraction), in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00.
Storage Environment Temperature00

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
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
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
10886982064745NA03.000.066S03000066S2016-06-30
10886982064820NA03.000.079S03000079S2016-06-30
10886982064844NA03.000.082S03000082S2016-06-30
10886982064882NA03.000.097S03000097S2016-06-30
10886982064905NA03.000.100S03000100S2016-06-30
10886982064929NA03.000.104S03000104S2016-06-30
10886982064936NA03.000.106S03000106S2016-06-30
10886982064943NA03.000.107S03000107S2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982346872MAXFRAMESynthes GmbHOSN2025-01-29
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982338778MAXFRAMESYNTHES (U.S.A.) LPOSN2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPOSN2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
07613327079241HOFFMANNStryker GmbHKTT2018-09-24
07613327079272HOFFMANNStryker GmbHKTT2018-09-24
07613327079333HOFFMANNStryker GmbHKTT2018-09-24
07613327079395HOFFMANNStryker GmbHKTT2018-09-24
07613327079401HOFFMANNStryker GmbHKTT2018-09-24
07613327079449HOFFMANNStryker GmbHKTT2018-09-24
07613327079470HOFFMANNStryker GmbHKTT2018-09-24
07613327079500HOFFMANNStryker GmbHKTT2018-09-24
07613327079517HOFFMANNStryker GmbHKTT2018-09-24
07613327079524HOFFMANNStryker GmbHKTT2018-09-24
07613327079586HOFFMANNStryker GmbHKTT2018-09-24