FDA.reportPublic FDA data

OASYS

Primary DI
04546540372055
Brand
OASYS
Company
Stryker Corporation
Model
48554416
Catalog number
48554416
Device description
BONE SCREW
Published
2015-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540372055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540372055045465403720554546540372055

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length16Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
149183167
Device count
1
DM exempt
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00081013188039 ION AO Coupling Cannulated Handle SURGENTEC, LLCMRW2026-03-09
00810131880330T-Handle 3/16" ConnectionSURGENTEC, LLCMRW2026-03-09
00810131881252 6.5/7.0 Drill BitSURGENTEC, LLCMRW2026-03-09
00810131881726ION Facet Screw SystemSURGENTEC, LLCMRW2026-03-09
00810131881788ION Cervical Disposable Instrument KitSURGENTEC, LLCMRW2026-03-09
00810131881795ION Disposable Instrument KitSURGENTEC, LLCMRW2026-03-09
00810131881801ION 55 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881818ION 60 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881825ION 65 Facet Implant - SterileSURGENTEC, LLCMRW2026-03-09
00810131881832 7.5 Drill BitSURGENTEC, LLCMRW2026-03-09
00810131881856ION Metal Drill Guide - LargeSURGENTEC, LLCMRW2026-03-09
00810131881986 ION Caddy with Metal PlateSURGENTEC, LLCMRW2026-03-09
00810131882051 Facet Locator - LargeSURGENTEC, LLCMRW2026-03-09
00810131882068 Impactor LargeSURGENTEC, LLCMRW2026-03-09
00810131882075Serrated Rasp - LargeSURGENTEC, LLCMRW2026-03-09
00810131882174ION Large TraySURGENTEC, LLCMRW2026-03-09
00810131882402 6.0mm Drill BitSURGENTEC, LLCMRW2026-03-09
00810131882419Plastic Removal Sleeve - Standard - 7.0-7.5SURGENTEC, LLCMRW2026-03-09
00810131882426Plastic Removal Sleeve - Standard - 5.5-6.5SURGENTEC, LLCMRW2026-03-09
00810131882723ION Cervical TraySURGENTEC, LLCMRW2026-03-09
00810131882747ION Lumbar TraySURGENTEC, LLCMRW2026-03-09
00810131882754ION Facet Screw SystemSURGENTEC, LLCMRW2026-03-09
03760418040667FFX Screw SC MEDICAMRW2025-11-26
03760418040674FFX Screw SC MEDICAMRW2025-11-26
03760418040681FFX Screw SC MEDICAMRW2025-11-26
03760418040698FFX Screw SC MEDICAMRW2025-11-26
03760418040704FFX Screw SC MEDICAMRW2025-11-26
03760418040711FFX Screw SC MEDICAMRW2025-11-26
03760418040728FFX Screw SC MEDICAMRW2025-11-26
03760418040735FFX Screw SC MEDICAMRW2025-11-26