Mastergraft Strip: FDA 510(k) K082166

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK082166	Date2 Jun 2009Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K082166

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K082166
FDA product code: MQV
FDA applicant: Medtronic Sofamor Danek

Device class: Class II
Regulation: 21 CFR Part 888.3045
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Mastergraft Putty K071813 9 Nov 2007 FDA record
Integra Mozaik Bone Regeneration Matrix - Strips K063124 19 Jan 2007 FDA record
Ossimend (Tm) Bone Graft Material K052812 25 Jan 2006 FDA record
Mastergraft Matrix K023553 22 Apr 2003 FDA record
Collagraft Strip Bone Graft Matrix (For Use As A Bone Filler), Model 1X, 3X, 6X (1, 3 Or 6 Strips Per Box) K000122 20 Sep 2001 FDA record

Cited by

Uni-FuZe-C Bone Strip K221726 18 Jan 2023 FDA record · FDA summary
MagnetOs Flex Matrix K213959 14 Apr 2022 FDA record · FDA summary
Sorrento Bone Graft Substitute K191074 27 Sep 2019 FDA record · FDA summary
MASTERGRAFT Contain K151172 14 Aug 2015 FDA record · FDA summary
Bongold Bone Graft Material K141725 9 Jul 2015 FDA record · FDA summary
Mastergraft Putty, Mastergraft Strip K140375 18 Apr 2014 FDA record · FDA summary
Mastergraft Strip; Mastergraft Ultramatrix K130335 19 Apr 2013 FDA record · FDA summary
NB3D Bone Void Filler K111944 22 Nov 2011 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K082166

9 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K082166
		UDI-DI	Size and differences
MASTERGRAFT® STRIP 7800310 MEDTRONIC SOFAMOR DANEK, INC.	7800310	00613994407818	Length 10.0 cm; Width 2.0 cm	On the market
MASTERGRAFT® STRIP 7800310 MEDTRONIC SOFAMOR DANEK, INC.	7800310	00643169486461	Width 2.0 cm; Length 10.0 cm	On the market
MASTERGRAFT® Strip 7800310 MEDTRONIC SOFAMOR DANEK, INC.	7800310	00643169719361	Width 2.0 cm; Depth 0.6 cm; Length 10.0 cm	On the market
MASTERGRAFT® STRIP 7800320 MEDTRONIC SOFAMOR DANEK, INC.	7800320	00643169486478	Width 2.0 cm; Length 10.0 cm	On the market
MASTERGRAFT® Strip 7800320 MEDTRONIC SOFAMOR DANEK, INC.	7800320	00643169719378	Length 10.0 cm; Depth 0.6 cm; Width 2.0 cm	On the market
MASTERGRAFT® STRIP 7800320 MEDTRONIC SOFAMOR DANEK, INC.	7800320	00613994407801	Length 10.0 cm; Width 2.0 cm	On the market
MASTERGRAFT® STRIP 7800336 MEDTRONIC SOFAMOR DANEK, INC.	7800336	00613994487339	Length 36.0 cm	On the market
MASTERGRAFT® STRIP 7800336 MEDTRONIC SOFAMOR DANEK, INC.	7800336	00643169486485	Width 2.0 cm; Length 36.0 cm	On the market
MASTERGRAFT® Strip 7800336 MEDTRONIC SOFAMOR DANEK, INC.	7800336	00643169719385	Depth 0.6 cm; Length 36.0 cm; Width 2.0 cm	On the market

Similar devices

Other devices filed under FDA product code MQV (Filler, Bone Void, Calcium Compound).

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Regulatory status

Coverage

Specification

Related clearances

Cites

Cited by

Devices cleared under K082166

Similar devices

Other devices from Medtronic Sofamor Danek, Inc.

MSB Reusable Instruments 9870005

MSB CD HORIZON Spinal System 6530530

T2 STRATOSPHERE™ Expandable Corpectomy System 436125C

MSB SHILLA Growth Guidance System 7670431