FDA.reportPublic FDA data

OsteoFab Suture Anchor

Primary DI
00850004435069
Brand
OsteoFab Suture Anchor
Company
OXFORD PERFORMANCE MATERIALS, INC.
Model
SA002-65
Device description
OsteoFab 6.5mm Suture Anchor
Published
2020-01-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBIFastener, Fixation, Nondegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004435090PackageGS15Not in Commercial Distribution
00850004435069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004435090008500044350908500044350900850004435090
00850004435069008500044350698500044350690850004435069

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810188325044HTR-PEKKPK6273702026-08-03
00810188325181HTR-PEKKPK6273732026-08-03
00810188325204HTR-PEKKPK6273802026-08-03
00810188325174HTR-PEKKPK6273792026-07-31
00850004435007OsteoFab Suture AnchorINS002-02-0012020-01-16
00850004435014OsteoFab Suture AnchorINS002-01-0012020-01-16
00850004435021OsteoFab Suture AnchorINS002-01-0022020-01-16
00850004435038OsteoFab Suture AnchorINS002-01-0032020-01-16
00850004435045OsteoFab Suture AnchorSA002-452020-01-16
00850004435052OsteoFab Suture AnchorSA002-552020-01-16
00810188325129HTR-PEKKPK6273742026-07-28
00810188325105HTR-PEKKPK6273572026-07-27
00810188325099HTR-PEKKPK627344-A2026-07-23
00810188325112HTR-PEKKPK6273722026-07-23
00810188325068HTR-PEKKPK6273712026-07-20
00810188325075HTR-PEKKPK627343-B2026-07-20
00810188325082HTR-PEKKPK627368-A2026-07-20
00810188325051HTR-PEKKPK6273272026-07-17
00810188324955HTR-PEKKPK6273592026-07-14
00810188325013HTR-PEKKPK6273692026-07-14

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00810146164692RedifixTRAX SURGICAL INC.MBI2026-07-20
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