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Xemplifi 8103.0201S

by Globus Medical, Inc.

Xemplifi 8103.0201S is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K103036 on 10 Jan 2011 and listed in FDA GUDID since 10 Oct 2015 (UDI-DI 00889095205893), 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) K103036

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 Number00889095205893 UDI-DI Date10 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103036 Date10 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103036 decided 10 Jan 2011 Active
  • FDA GUDID UDI-DI 00889095205893 listed 10 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103036
  2. Listed FDA GUDID 00889095205893

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Xemplifi
Generic name
Human-derived demineralized bone matrix implant
Model / reference
8103.0201S
Primary DI / UDI-DI
00889095205893
510(k) Number
FDA product code
MQV, MBP
GMDN term
Human-derived demineralized bone matrix implant
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1 Milliliter

Related devices

Category: Bone matrix implant, human-derived

Cleared under the same submission (K103036)

and 8 more cleared under K103036

Similar devices

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

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

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