FDA.reportPublic FDA data

OsteoMed

Primary DI
00842528114056
Brand
OsteoMed
Company
OSTEOMED LLC
Model
218-0235-SP
Catalog number
218-0235-SP
Device description
Translabyrinthine plate, L, Sterile
Published
2018-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWOPlate, cranioplasty, preformed, alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842528114056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842528114056008425281140568425281140560842528114056

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length64Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)456-7779Customer.Service@osteomed.com

Regulatory Flags#

DUNS number
606417780
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842528129722OsteoMed336-9101336-91012023-10-13
00842528129739OsteoMed336-9102336-91022023-10-13
00842528129746OsteoMed336-9103336-91032023-10-13
00842528129753OsteoMed336-9104336-91042023-10-13
00842528129760OsteoMed336-9105336-91052023-10-13
00842528129777OsteoMed336-9106336-91062023-10-13
00842528129784OsteoMed336-9107336-91072023-10-13
00842528129791OsteoMed336-9108336-91082023-10-13
00842528129807OsteoMed336-9109336-91092023-10-13
00842528129814OsteoMed336-9110336-91102023-10-13
00842528129821OsteoMed336-9111336-91112023-10-13
00842528129838OsteoMed336-9112336-91122023-10-13
00842528129845OsteoMed336-9201336-92012023-10-13
00842528129852OsteoMed336-9202336-92022023-10-13
00842528129869OsteoMed336-9203336-92032023-10-13
00842528129876OsteoMed336-9204336-92042023-10-13
00842528129883OsteoMed336-9205336-92052023-10-13
00842528129890OsteoMed336-9206336-92062023-10-13
00842528129906OsteoMed336-9207336-92072023-10-13
00842528129913OsteoMed336-9208336-92082023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012759477TECHFITTechfit Digital Surgery, Inc.GWO2025-12-30
00860012759484TECHFITTechfit Digital Surgery, Inc.GWO2025-12-30
00860012759491TECHFITTechfit Digital Surgery, Inc.GWO2025-12-30
00860014930904TECHFITTechfit Digital Surgery, Inc.GWO2025-12-30
00860014930911TECHFITTechfit Digital Surgery, Inc.GWO2025-12-30
00860014930928TECHFITTechfit Digital Surgery, Inc.GWO2025-12-30
00816847022675VSP PEEK3D SYSTEMS, INC.GWO2024-09-12
07613327635102NAStryker Leibinger GmbH & Co. KGGWO2024-07-10
07613327635119NAStryker Leibinger GmbH & Co. KGGWO2024-07-10
00841036285982COMPLETE CMF RACK SYSTEM BLKBIOMET MICROFIXATION, INCGWO2024-06-03
07613327300024NAStryker Leibinger GmbH & Co. KGGWO2024-04-10
07613327628227UNIVERSAL NEURO 3Stryker Leibinger GmbH & Co. KGGWO2023-10-20
00898142001937NeuroPro® Low ProfileKinamed, Inc.GWO2023-05-15
07613327600971UNIVERSAL NEURO 3Stryker Leibinger GmbH & Co. KGGWO2022-10-24
G28433001NuCrani Small PlateNeurovention LLCGWO2022-06-21
G28436102NuCrani Large PlateNeurovention LLCGWO2022-06-21
07613327300048NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
07613327300086NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
07613327300109NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
07613327300123NAStryker Leibinger GmbH & Co. KGGWO2021-01-27
07613327539387Universal Neuro 3Stryker Leibinger GmbH & Co. KGGWO2020-11-09
07613327524147UNIVERSAL NEURO 3Stryker Leibinger GmbH & Co. KGGWO2020-10-14
07613327520507UNIVERSAL NEURO 3Stryker Leibinger GmbH & Co. KGGWO2020-08-20
07613327520514UNIVERSAL NEURO 3Stryker Leibinger GmbH & Co. KGGWO2020-08-20
008882330015951.5MM SYSTEMBIOMET MICROFIXATION, INCGWO2020-06-18
008882330016181.5MM SYSTEMBIOMET MICROFIXATION, INCGWO2020-06-18
00888233001649THINFLAP SYSTEMBIOMET MICROFIXATION, INCGWO2020-06-18
00888233025324THINFLAP SYSTEMBIOMET MICROFIXATION, INCGWO2020-06-18
00888233006804NEURO SYSTEMBIOMET MICROFIXATION, INCGWO2020-06-17
00888233006828NEURO SYSTEMBIOMET MICROFIXATION, INCGWO2020-06-17