FDA.reportPublic FDA data

StayFuse™

Primary DI
00846832009688
Brand
StayFuse™
Company
TORNIER, INC.
Model
STA-P4
Catalog number
STA-P4
Device description
PROXIMAL FUSION IMPLANT
Published
2015-10-16
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
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022726000STAYFUSE GT-IPPioneer Surgical Technology2002-09-06HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832009688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832009688008468320096888468320096880846832009688

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840338607515Made-To-Order902706990270692026-04-28
00840338604033Tornier HRSARS10252ARS102522025-11-18
00840338604040Tornier HRSARS10253ARS102532025-11-18
00846832068678AEQUALIS™ FLEX REVIVE™ARS742301ARS7423012019-03-04
00846832068685AEQUALIS™ FLEX REVIVE™ARS742302ARS7423022019-03-04
00846832068692AEQUALIS™ FLEX REVIVE™ARS742303ARS7423032019-03-05
00846832068708AEQUALIS™ FLEX REVIVE™ARS742304ARS7423042019-03-04
00846832068715AEQUALIS™ FLEX REVIVE™ARS742305ARS7423052019-03-04
00846832068722AEQUALIS™ FLEX REVIVE™ARS742306ARS7423062019-03-04
00846832068739AEQUALIS™ FLEX REVIVE™ARS742401ARS7424012019-03-04
00846832068746AEQUALIS™ FLEX REVIVE™ARS742402ARS7424022019-03-04
00846832068777AEQUALIS™ FLEX REVIVE™ARS742405ARS7424052019-03-04
00846832068784AEQUALIS™ FLEX REVIVE™ARS742406ARS7424062019-03-04
00846832068814AEQUALIS™ FLEX REVIVE™ARS742501ARS7425012019-03-04
00846832068821AEQUALIS™ FLEX REVIVE™ARS742502ARS7425022019-03-04
00846832068838AEQUALIS™ FLEX REVIVE™ARS742503ARS7425032019-03-04
00846832068845AEQUALIS™ FLEX REVIVE™ARS742504ARS7425042019-03-04
00846832068852AEQUALIS™ FLEX REVIVE™ARS742505ARS7425052019-03-04
00846832068869AEQUALIS™ FLEX REVIVE™ARS742506ARS7425062019-03-04
00846832006588Futura™ FGTFGT-202015-10-16

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