FDA.report

Phenix

Primary DI
00840916114657
Brand
Phenix
Company
SPINAL ELEMENTS
Model
10201-171422L
Device description
Phenix CID Sharp Teeth Implant, 17 x 14 x 22mm, Lordotic, Lat Window
Published
2017-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

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
00840916114657PrimaryGS10

GMDN Terms

TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods

Method

Regulatory Flags

DUNS number
004022104
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
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

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00840916161842ZEUS-L101272021-04-09
00840916161859ZEUS-L18-10402021-04-09
00840916161866ZEUS-L05-10-32021-04-09
00840916150693SAVANNAHSP-0264-6.52020-04-29
00840916161989DIAMOND70012022-03-03
00840916161996DIAMOND100112022-03-03
00840916162009DIAMOND100162022-03-03
00840916162023DIAMOND10013-102022-03-03
00840916162030DIAMOND10013-122022-03-03
00840916162047DIAMOND10013-142022-03-03
00840916162054DIAMOND10013-162022-03-03
00840916162061DIAMOND10013-182022-03-03
00840916162078DIAMOND10014-402022-03-03
00840916162085DIAMOND10021-B2022-03-03
00840916162092DIAMOND10025-2-F-B2022-03-03
00840916162108DIAMOND10025-2-V-B2022-03-03
00840916162115DIAMOND100402022-03-03
00840916162122DIAMOND100432022-03-03
00840916162139DIAMOND100472022-03-03
00840916162146DIAMOND100482022-03-03

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00840283403194LumiVy™VY SPINE LLCMAX2026-03-24
00840283403200LumiVy™VY SPINE LLCMAX2026-03-24
00840283403217LumiVy™VY SPINE LLCMAX2026-03-24
00840283403224LumiVy™VY SPINE LLCMAX2026-03-24
06009527200096TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200102TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200119TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200126TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200133TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200140TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200157TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200164TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200218TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200225TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200232TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200249TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200256TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200263TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
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03662663130936Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
03662663131117Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
04052536018192pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018208pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018215pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018222pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018239pezoUlrich GmbH & Co. KGMAX2026-03-16
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04052536018260pezoUlrich GmbH & Co. KGMAX2026-03-16