FDA.report

Cervalign

Primary DI
00810076561806
Brand
Cervalign
Company
Surgalign Spine Technologies, Inc.
Model
66-CALIPER
Device description
PLATE SIZING CALIPER
Published
2023-06-13
Public version status
New
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
KTZCALIPER

Product Code Classifications

CodeDeviceSpecialtyClass
KTZCaliperOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810076561806PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(844)894-7752customerservice@surgalign.com

Regulatory Flags

DUNS number
014520584
Device count
1
DM exempt
false
Premarket exempt
true
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

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00810076562445Cortera150100-450702023-01-06
00810076562452Cortera150100-450752023-01-06
00810076562469Cortera150100-450802023-01-06
00810076562476Cortera150100-450852023-01-06
00810076562483Cortera150100-450902023-01-06
00810076562490Cortera150100-450952023-01-06
00810076562506Cortera150100-451002023-01-06

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