Skip to content

Sochi A16-10-3518

by Altus Spine

Sochi A16-10-3518 is a Class II device made by Altus Spine, cleared under FDA 510(k) K210887 on 20 Aug 2021 and listed in FDA GUDID since 28 Dec 2023 (UDI-DI 00843210166254), active as of 23 Oct 2026.

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) K210887

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843210166254 UDI-DI Date28 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210887 Date20 Aug 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210887 decided 20 Aug 2021 Active
  • FDA GUDID UDI-DI 00843210166254 listed 28 Dec 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210887
  2. Listed FDA GUDID 00843210166254

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sochi
Generic name
Spinal bone screw, non-bioabsorbable
Model / reference
A16-10-3518
Primary DI / UDI-DI
00843210166254
510(k) Number
FDA product code
KWP, NKB
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3050, 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 (K210887)

and 8 more cleared under K210887

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

Other devices from Altus Spine

See all devices from Altus Spine →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)