CAMBER SPINE TECHNOLOGIES, LLC

Address:501 Allendale Rd,King of Prussia,PA,19406,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD) (7) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (3) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (1) Orthosis, Spinal Pedicle Fixation (MNI) (1) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (1)

Premarket Exempt

Clear

Enza - B030CB0010350 Catalog Number :

Device Description : 15°, Lordotic,32mm x 38mm,21mm

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Enza - B030CB0010370 Catalog Number :

Device Description : Intervertebral Locking Plate , 23mm x 28mm

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Enza - B030CB0010380 Catalog Number :

Device Description : Intervertebral Locking Plate , 26mm x 32mm

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Enza - B030CB0010390 Catalog Number :

Device Description : Intervertebral Locking Plate , 32mm x 38mm

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Orthros - B030CC002030 Catalog Number : CC-002-03

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Enza - B030CC002360 Catalog Number :

Device Description : Locking Set Screw

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Enza - B030CC002370 Catalog Number :

Device Description : Locking Set Screw

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Enza - B030CC002380 Catalog Number :

Device Description : Locking Set Screw

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Orthros - B030CC004010 Catalog Number : CC-004-01

Device Description : Ø4.5mm Polyaxial Pedicle Screw, 25mm Lg.

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : NKB, MNI, MNH, KWQ

Prescription Use : Yes

Device Count : 1

Orthros - B030CC004020 Catalog Number : CC-004-02

Device Class : 2

Duns Number: 054205979

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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