FDA.report

OsteoMed

Primary DI
00845694047104
Brand
OsteoMed
Company
OSTEOMED LLC
Model
816-1130-SP
Catalog number
816-1130-SP
Device description
PrimaLIF LLIF PEEK Implant, 11mm X 22mm X 30mm, Lordotic, Sterile
Published
2015-06-01
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
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00845694047104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00845694047104008456940471048456940471040845694047104

GMDN Terms

TermDefinition
Orthopaedic fixation plate kit, non-bioabsorbable, sterileA sterile collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Device Sizes

TypeValueUnit
Length30Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature out of direct sunlight

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800322740446Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740453Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740460Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740477Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740484Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740491Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740507Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740514Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740521Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740538Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740545Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740552Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740569Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740576Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740583Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740590Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740606Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740613Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740620Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740637Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740644Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740651Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740668Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740675Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740682Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740699Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740705Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740712Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740729Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23
08800322740736Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-23