FDA.report

OsteoMed

Primary DI
00845694031851
Brand
OsteoMed
Company
OSTEOMED LLC
Model
800-1135-SP
Catalog number
800-1135-SP
Device description
PrimaLOK FF 35mm Implant Assembly, Sterile
Published
2015-05-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MRWSYSTEM, FACET SCREW SPINAL DEVICE

Product Code Classifications

CodeDeviceSpecialtyClass
MRWSystem, Facet Screw Spinal DeviceUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694031851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694031851008456940318518456940318510845694031851

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes

TypeValueUnit
Length35Millimeter

Sterilization Methods

Method

Contacts

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
false
Expiration date on label
true
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 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

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00081013188039 ION AO Coupling Cannulated Handle SURGENTEC, LLCMRW2026-03-09
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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
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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