FDA.reportPublic FDA data

NA

Primary DI
10888551027823
Brand
NA
Company
STERILMED, INC.
Model
STR6007-425-000
Catalog number
STR6007-425-000
Device description
STRYKER ANCHORING PIN
Published
2015-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDMPIN, FIXATION, THREADED, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDMPin, Fixation, Threaded, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100707000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100707000REPROCESSED PINSSterilmed, Inc.2010-06-25NDM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551027823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855102782310888551027823

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
Sterilization required before use
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
10888551027793NASTERILMED, INC.NDM2015-09-22
10888551027809NASTERILMED, INC.NDM2015-09-22
10888551027816NASTERILMED, INC.NDM2015-09-22
10888551027830NASTERILMED, INC.NDM2015-09-22
10888551027847NASTERILMED, INC.NDM2015-09-22
10888551027854NASTERILMED, INC.NDM2015-09-22
10888551027861NASTERILMED, INC.NDM2015-09-22