FDA.reportPublic FDA data

FIREBIRD SFS

Primary DI
18257200047420
Brand
FIREBIRD SFS
Company
Orthofix US LLC
Model
52-1501
Device description
BONE AWL, CANNULATED
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAWL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18257200047420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1825720004742018257200047420

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)527-0404customerservice@orthofix.com

Regulatory Flags#

DUNS number
927083808
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18257200066421Orthofix Proview70-23002016-07-14
18257200066438Orthofix Proview70-23012016-07-14
18257200066445Orthofix Proview70-23022016-07-14
18257200066452Orthofix Proview70-23032016-07-14
28257200066497Orthofix Proview70-23042016-07-14
00850071315226TrendDCT-0180DCT-01802026-04-25
00850071315264TrendDCT-3951DCT-39512026-04-25
00850071315295TrendDCT-6061T-2DCT-6061T-22026-04-25
00850071315301TrendDCT-6061T-3DCT-6061T-32026-04-25
00850071315332TrendDCT-6061S-2DCT-6061S-22026-04-25
00850071315356TrendDCT-6061S-4DCT-6061S-42026-04-25
00850071315370TrendDCT-1971-2DCT-1971-22026-04-25
00850071315387TrendDCT-1971-4DCT-1971-42026-04-25
00850071315400TrendDCT-908-RDCT-908-R2026-04-25
00850071315417TrendDCT-908-LDCT-908-L2026-04-25
00850071315448TrendDCT-200-RDCT-200-R2026-04-25
00850071315455TrendDCT-200-LDCT-200-L2026-04-25
00850071315509TrendVSL-747-LGVSL-747-LG2026-04-25
00850071315516TrendDCT-3960DCT-39602026-04-25
00850071315462TrendDCT-1516-RDCT-1516-R2026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311245376Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWJ2026-04-30
04048844406547n/aimplantcast GmbHHWJ2026-04-07
04052536216161uCentumUlrich GmbH & Co. KGHWJ2026-03-31
00860015151308EnFix Instrument Kit - CompleteTETROUS, INC.HWJ2026-02-24
00887868287473Trinica ALP Anterior Lumbar Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663108126Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663109949InViZia Anterior Cervical Plate SystemHighridge Medical, LLCHWJ2025-11-12
03662663128759PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHWJ2025-11-12
03662663129015Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHWJ2025-11-12
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
00763000674410n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-26
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
00763000878245n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-20
00840180541050General InstrumentsALPHATEC SPINE, INC.HWJ2025-10-17
00763000885243n/aMEDTRONIC SOFAMOR DANEK, INC.HWJ2025-10-11
00816342025522AWLPARCUS MEDICAL LLCHWJ2025-09-16
04047844128190CYLOX STSIGNUS Medizintechnik GmbHHWJ2025-05-27
04047844128206CYLOX STSIGNUS Medizintechnik GmbHHWJ2025-05-27
00841732134393GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134409GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134416GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732134423GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732135406GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139411GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732139428GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-10-07
00841732163850GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14
00841732163935GENERIC Surgical InstrumentsCTL Medical CorporationHWJ2023-09-14
008100747560374WEB Medical4web MedicalHWJ2023-02-13