FDA.reportPublic FDA data

REUNITE SCREW SYSTEM

Primary DI
00880304424784
Brand
REUNITE SCREW SYSTEM
Company
Biomet Orthopedics, LLC
Model
948830
Catalog number
948830
Published
2015-10-24
Public version status
Update
Distribution status
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
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992301000REUNITE SCREWSBiomet Manufacturing, Inc.1999-09-01HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304424784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304424784008803044247848803044247840880304424784

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, bioabsorbableA small, 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 is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
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
07901125620742Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620759Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620773Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620780Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620797Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620803Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620810Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620827Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620834Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620841Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620858Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620865Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620872Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620889Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620896Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620902Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620919Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620926Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620933Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620940Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620957Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620964Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620971Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620988Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-27
07901125620537Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620544Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620551Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620568Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620575Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26
07901125620711Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-08-26