FDA.reportPublic FDA data

NA

Primary DI
10888551044714
Brand
NA
Company
STERILMED, INC.
Model
STR4922-8-300
Catalog number
STR4922-8-300
Device description
STRYKER Ø11 × 300MM CONNECTING ROD - CARBON
Published
2015-09-22
Public version status
Update
Distribution status
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
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081586000REPROCESSED EXTERNAL FIXATION DEVICESterilmed, Inc.2008-08-18KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551044714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855104471410888551044714

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system reprocessed componentA component of an external fixation system intended to be used to stabilize a fractured bone/joint. It may be a specially designed frame, clamp, rod, pin, rod-to-rod coupling, rod-to-pin coupling, post, fastener, wire, bolt, washer, nut, hinge, ring, socket, bar, screw, or other device. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551045735Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on GE SystemR11657485R116574852026-07-06
10888551045742Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on GE SystemR11657484R116574842026-07-06
10888551045759Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on Siemens SystemR11510825R115108252026-07-06
10888551045766Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on Siemens SystemR11510826R115108262026-07-06
10888551001205NAMED5455SLMED5455SL2016-09-22
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15

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
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
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
07613327079609HOFFMANNStryker GmbHKTT2018-09-24
07613327079623HOFFMANNStryker GmbHKTT2018-09-24
10886982260659MAXFRAMESynthes GmbHKTT2017-04-19