FDA.report

Vu a-POD™

Primary DI
10889981041809
Brand
Vu a-POD™
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
21-23-2716
Catalog number
21-23-2716
Device description
27x21mm Trial Rasp 16mm 8 deg
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K121211000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K121211000VU APOD INTERVERTEBRAL BODY FUSION DEVICETheken Spine, LLC2012-06-27OVD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889981041809PrimaryGS10

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags

DUNS number
079840876
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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10889981135331Newport Complex MIS64-552564-55252026-03-03
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10889981135997Newport Complex MIS64-851064-85102026-03-03
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10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03
10889981145903NewPort™65-653565-65352026-03-03

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Primary DIBrandCompanyProduct codePublished
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
10889981304713MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
00840067210710TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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00840067210956TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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