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Orthros ORT-5550

by Camber Spine Technologies

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 23 Oct 2026

Documents

510(k) K133366

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB030ORT55500 UDI-DI Date24 Jan 2019ListedStatusListed 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 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Orthros
Generic name
Spinal bone screw, non-bioabsorbable
Model / reference
ORT-5550
Primary DI / UDI-DI
B030ORT55500
510(k) Number
FDA product code
NKB, MNI, MNH, KWQ
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3070, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 50 Millimeter

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