FDA.reportPublic FDA data

RAPIDFLAP (TM) SYSTEM

Primary DI
00888233011259
Brand
RAPIDFLAP (TM) SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
75-1030-12
Catalog number
75-1030-12
Published
2020-06-18
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
GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031034000SPIN DOWN RAPIDFLAPWalter Lorenz Surgical, Inc.2003-05-21GXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233011259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233011259008882330112598882330112590888233011259

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small implantable plate/set of plates designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole; the material cannot be chemically degraded or absorbed by natural body processes. It is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover) and includes implant-grade metal; in addition to the plate(s) bone screws may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233025140N/A02-290202-29022020-06-26
00888233025157N/A02-290502-29052020-06-26
00888233025164N/A02-310102-31012020-06-26
00888233025171N/A02-310202-31022020-06-26
00888233025188N/A02-310502-31052020-06-26
00888233025195N/A02-311002-31102020-06-26
00888233025201N/A7014-32667014-32662020-06-26
00841036125844ALLOGENIX02-31012015-09-24
00841036125851ALLOGENIX02-31022015-09-24
00841036125868ALLOGENIX02-31052015-09-24
00841036125875ALLOGENIX02-31102015-09-24
00841036181468ALLOGENIX PLUS02-29022015-09-24
00841036181475ALLOGENIX PLUS02-29052015-09-24
00841036019112N/A02-008302-00832017-06-05
00888233028875Pectus Blu (TM)78-880178-88012026-07-23
00888233028882Pectus Blu (TM)78-880278-88022026-07-23
00888233028899Pectus Blu (TM)78-880378-88032026-07-23
00888233086110Pectus Blu (TM)78-005378-00532026-07-23
00888233086127Pectus Blu (TM)78-005578-00552026-07-23
00888233086134Pectus Blu (TM)78-720078-72002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325662HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-22
00810188325952HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-21
00810188325969HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-21
00810188325976HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-21
00810188325839HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325914HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325938HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-20
00810188325945HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-19
00810188325884HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-14
00810188325891HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-14
00810188325853HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-13
00810188325563HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325815HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325860HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325877HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-12
00810188325846HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-09
00810188325785HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-08
00810188324801HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-07
00810188325761HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-07
00810188325617HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-06
00810188325778HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-06
00810188325716HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325792HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325808HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-10-05
00810188325709HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-30
00810188325600HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-29
00810188325655HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-28
00810188325594HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-25
00810188325679HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-24
00810188325624HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-21