FDA.report

LEOS

Primary DI
00196449000692
Brand
LEOS
Company
Tyber Medical LLC
Model
7620-3526
Catalog number
7620-3526
Device description
LEOS 3.5mm Non-Locking Screw, 26mm
Published
2022-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K222465000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K222465000Tyber Medical Anatomical Plating SystemTyber Medical, LLC2023-03-07HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00196449000692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449000692001964490006921964490006920196449000692

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)761-0933mschenk@tybermed.com
+1(866)761-0933nmerlini@tybermed.com

Regulatory Flags

DUNS number
010968002
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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