FDA.reportPublic FDA data

FRS™SCREW

Primary DI
00887868116216
Brand
FRS™SCREW
Company
Biomet Orthopedics, LLC
Model
P3018
Catalog number
P3018
Published
2015-10-24
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
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062352000
K962236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062352000FRS SCREWDePuy Orthopaedics, Inc.2006-10-19HWC
K962236000SCARF THREAD-HEAD SCREWLandos, Inc.1996-09-20HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868116216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868116216008878681162168878681162160887868116216

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07901125621176Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-09-18
07901125621183Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-09-18
07901125621190Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-09-18
07901125621206Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-09-18
00885556838303Total Foot System 2Smith & Nephew, Inc.HWC2023-04-25
00885556838327Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00885556824764DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824771DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824788DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824795DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824818DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824825DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556835043Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835050Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835081Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835098Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835111Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835128Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835135Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835142Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835159Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835173Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836187Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836484Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836163Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836170Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836194Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836200Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836217Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836392Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22