FDA.reportPublic FDA data

OsteoFab Suture Anchor

Primary DI
00850004435014
Brand
OsteoFab Suture Anchor
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
INS002-01-001
Device description
2mm OsteoFab Suture Anchor Awl
Published
2020-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00850004435014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004435014008500044350148500044350140850004435014

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-860-698-9300CustomerService@oxfordpm.com

Regulatory Flags#

DUNS number
962301359
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810188324177HTR-PEKKPK6272892026-06-09
00810188324719HTR-PEKKPK627301-A2026-06-09
00810188324689HTR-PEKKPK627326-A2026-06-03
00810188324665HTR-PEKKPK6273342026-06-01
00810188324641HTR-PEKKPK627330-A2026-05-28
00810188324658HTR-PEKKPK6273332026-05-28
00810188324634HTR-PEKKPK627331-A2026-05-27
00810188324511HTR-PEKKPK6273202026-05-26
00810188324603HTR-PEKKPK627324-A2026-05-26
00810188324627HTR-PEKKPK6273322026-05-26
00810188324573HTR-PEKKPK6273292026-05-22
00810188324597HTR-PEKKPK6273282026-05-22
00810188324214HTR-PEKKPK6272882026-05-21
00810188324429HTR-PEKKPK6273112026-05-19
00810188324320HTR-PEKKPK6273002026-05-18
00810188324559HTR-PEKKPK627291-A2026-05-18
00810188324566HTR-PEKKPK6273252026-05-18
00810188324535HTR-PEKKPK627270-A2026-05-15
00810188324542HTR-PEKKPK6273152026-05-14
00810188324528HTR-PEKKPK6273232026-05-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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