Skip to content

MASTERGRAFT® Contain 7800510

by Medtronic Sofamor Danek, Inc.

MASTERGRAFT® Contain 7800510 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K151172 on 14 Aug 2015 and listed in FDA GUDID since 27 Aug 2015 (UDI-DI 00643169585461), 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) K151172

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 Number00643169585461 UDI-DI Date27 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151172 Date14 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151172 decided 14 Aug 2015 Active
  • FDA GUDID UDI-DI 00643169585461 listed 27 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151172
  2. Listed FDA GUDID 00643169585461

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MASTERGRAFT® Contain
Generic name
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Model / reference
7800510
Primary DI / UDI-DI
00643169585461
510(k) Number
FDA product code
MQV
GMDN term
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Height — 2.0 Centimeter
Depth — 1.2 Centimeter
Length — 10.0 Centimeter

Related devices

Category: Bone matrix implant, synthetic, non-antimicrobial

Cleared under the same submission (K151172)

Similar devices

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

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)