FDA.reportPublic FDA data

OsteoMed

Primary DI
00845694066020
Brand
OsteoMed
Company
OSTEOMED LLC
Model
218-1605-SP-10
Catalog number
218-1605-SP-10
Device description
Profile 0 5mm AutoDrive Screw Sterile Qty 10
Published
2015-07-02
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
00845694066020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694066020008456940660208456940660200845694066020

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter

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
true
Expiration date on label
false
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