FDA.reportPublic FDA data

MetaFix™ LS Locking Screw

Primary DI
04048266024596
Brand
MetaFix™ LS Locking Screw
Company
Merete GmbH
Model
3.0 32 Hex2.5
Catalog number
FH30032
Device description
TiAl6V4 ELI non-sterile
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K063487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063487000MERETE BLP SMALL FRAGMENT LOCKING BONE PLATEMerete Medical GmbH2007-01-22KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048266024596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048266024596040482660245964048266024596

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length32Millimeter
Outer Diameter3Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(630)869-1092service@merete.medical.com

Regulatory Flags#

DUNS number
313267265
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048266076762N/AFH20014FH200142021-11-01
04048266079077OsteoBridge™N/AGA314132021-11-01
04048266079107OsteoBridge™N/AGA316132021-11-01
04048266079114OsteoBridge™N/AGA316152021-11-01
04048266079138OsteoBridge™N/AGA414132021-11-01
04048266079145OsteoBridge™N/AGA414152021-11-01
04048266079152OsteoBridge™N/AGA414202021-11-01
04048266079169OsteoBridge™N/AGA416132021-11-01
04048266079183OsteoBridge™N/AGA416202021-11-01
04048266079190OsteoBridge™N/AGA418132021-11-01
04048266131003OsteoBridge™N/AGA314202021-11-01
04048266138200OsteoBridge™N/AGA414252021-11-01
04048266144294OsteoBridge™N/AGA318152021-11-01
04048266130853OsteoBridge™ IKA Knee Arthrodesis Nailwithout Collar curved 20 300GA220302015-10-15
04048266078780OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 10 130GA110132015-10-15
04048266078797OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 10 150GA110152015-10-15
04048266078827OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 12 150GA112152015-10-15
04048266078841OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 14 130GA114132015-10-15
04048266078858OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 14 150GA114152015-10-15
04048266078872OsteoBridge™ IKA Knee Arthrodesis Nailwith Collar 16 130GA116132015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09353903016311NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2026-04-13
09353903016328NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2026-04-13
03700569604233NANEWCLIP TECHNICSHWC2024-11-15
03700569604257NANEWCLIP TECHNICSHWC2024-11-15
03700569604271NANEWCLIP TECHNICSHWC2024-11-15
03700569604295NANEWCLIP TECHNICSHWC2024-11-15
03700569604318NANEWCLIP TECHNICSHWC2024-11-15
03700569604332NANEWCLIP TECHNICSHWC2024-11-15
03700569604356NANEWCLIP TECHNICSHWC2024-11-15
03700569604370NANEWCLIP TECHNICSHWC2024-11-15
03700569633936NANEWCLIP TECHNICSHWC2024-11-15
03700569633950NANEWCLIP TECHNICSHWC2024-11-15
03700569633974NANEWCLIP TECHNICSHWC2024-11-15
03700569633998NANEWCLIP TECHNICSHWC2024-11-15
03700569634018NANEWCLIP TECHNICSHWC2024-11-15
03700569634032NANEWCLIP TECHNICSHWC2024-11-15
03700569634056NANEWCLIP TECHNICSHWC2024-11-15
09353903015376NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015383NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015390NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015406NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015413NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015420NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015437NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015444NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015451NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015468NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015475NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015482NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015499NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16