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Orthros

by Camber Spine Technologies 222 variants

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 31 May 2026

Documents

510(k) K133366

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 31 May 2026. What this means

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB030CC007030 UDI-DI Date26 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133366 Date8 Apr 2014DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 31 May 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
Ø5.5mm Cannulated Polyaxial Reduction Pedicle Screw, 35mm Lg., CC-007-03
Primary DI / UDI-DI
B030CC007030
510(k) Number
FDA product code
NKB
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K133366)

Show all (12)

Other devices from Camber Spine Technologies

See all devices from Camber Spine Technologies →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date

Other properties (9)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No