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Vitoss 2102-1101

by Stryker Corp.

Vitoss 2102-1101 is an orthopaedic bone void filling material (FDA Class II; FDA product code MQV, Filler, Bone Void, Calcium Compound) made by Stryker Corp., cleared under FDA 510(k) K032288 on 19 Dec 2003 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00808232000276), 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) K032288

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 Number00808232000276 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK032288 Date19 Dec 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K032288 decided 19 Dec 2003 Active
  • FDA GUDID UDI-DI 00808232000276 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K032288
  2. Listed FDA GUDID 00808232000276

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vitoss
Generic name
Orthopaedic bone void filling material, synthetic/animal-derived
Model / Ref / Catalog
2102-1101
Primary DI / UDI-DI
00808232000276
510(k) Number
FDA product code
MQV
GMDN term
Orthopaedic bone void filling material, synthetic/animal-derived
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution
Size
Length — 240.0 Millimeter
Width — 25.0 Millimeter
Height — 4.0 Millimeter

Related devices

Category: Bone matrix implant, composite

Cleared under the same submission (K032288)

and 5 more cleared under K032288

Similar devices

Other devices filed under FDA product code MQV (FILLER, BONE VOID, CALCIUM COMPOUND).

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)