What is FDA product code OVD?

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Endoskeleton® TAS · Intervertebral Fusion Device with Integrated Fixation, Lumbar → Orthopedic

Name: Endoskeleton® TAS
Brand: Endoskeleton® TAS

3manufacturers in China registered for this device type

271catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVD
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Zibo Dante Co., Ltd.	Zibo	Shandong	Contract manufacturer	17
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53

Record

Regulatory record for Endoskeleton® TAS
Listed by	Titan Spine, LLC, United States
FDA product code	OVD
Device type	Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class	Class 2
Regulation	21 CFR 888.3080
510(k)	K111626
Record published	2016-12-15
Record revised	2022-09-16 (version 12)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Sizes	Height 8 to 17 mm; width 32 to 40 mm; depth 21 to 27 mm; angle 7 to 12 °; length 2 to 23 in; width 1.5 to 11 in; height 1.25 to 6 in; outer diameter 5.5 to 6.5 mm
Distribution end date	2022-05-04
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Endoskeleton® TAS
Catalogue number	Size	Status
905-020-001		In distribution
2300-1312		In distribution
1000-0068		In distribution
2312-1111	Width 36 mm	In distribution
2300-1315		In distribution
2312-1114	Width 36 mm	Withdrawn
2312-0112-N	Height 12 mm	Withdrawn
2312-0115	Height 15 mm	Withdrawn
2312-9415	Height 15 mm	Withdrawn
2307-0113	Height 13 mm	Withdrawn
2307-0211	Lordotic Angle 7 Deg	Withdrawn
2112-9313	Lordotic Angle 12 Deg	Withdrawn
2312-0315-S	Lordotic Angle 12 Deg	Withdrawn
2312-1113	Lordotic Angle 12 Deg	Withdrawn
2312-1113-N	Lordotic Angle 12 Deg	Withdrawn
2307-9009	Height 9 mm	Withdrawn
2307-0312	Lordotic Angle 7 Deg	Withdrawn
2112-9215	Lordotic Angle 12 Deg	Withdrawn
2307-0110-S	Lordotic Angle 7 Deg	Withdrawn
2312-9413	Height 13 mm	Withdrawn
2312-0315	Height 15 mm	Withdrawn
2112-9316	Height 16 mm	Withdrawn
2312-1112	Lordotic Angle 12 Deg	Withdrawn
2307-0115-S	Height 15 mm	Withdrawn
2300-1317	Width 1.5 in	Withdrawn
2300-1039	Width 4 in	Withdrawn
2307-0314-N	Height 14 mm	Withdrawn
2307-0212	Height 12 mm	Withdrawn
2307-0111-N	Lordotic Angle 7 Deg	Withdrawn
2312-0112-S	Height 12 mm	Withdrawn
2312-0116-N	Height 16 mm	Withdrawn
2312-1110-N	Height 10 mm	Withdrawn
2312-0211-N	Lordotic Angle 12 Deg	Withdrawn
2312-0211-S	Height 11 mm	Withdrawn
2300-6530	Outer Diameter 6.5 mm	Withdrawn
2900-1016	Length 23 in	Withdrawn
2112-9113	Height 13 mm	Withdrawn
2300-5520	Length 20 mm	Withdrawn
2312-1116	Angle 12 °	Withdrawn
2307-0313-S	Lordotic Angle 7 Deg	Withdrawn
2112-9309	Lordotic Angle 12 Deg	Withdrawn
2900-1006	Height 3.5 in	Withdrawn
2307-0215-S	Height 15 mm	Withdrawn
2312-0311-N	Lordotic Angle 12 Deg	Withdrawn
2112-9314	Lordotic Angle 12 Deg	Withdrawn
2307-0317	Height 17 mm	Withdrawn
2312-1117-N	Lordotic Angle 12 Deg	Withdrawn
2112-9310	Lordotic Angle 12 Deg	Withdrawn
2112-9213	Lordotic Angle 12 Deg	Withdrawn
2312-0111-S	Height 11 mm	Withdrawn
2300-1301	Length 9.5 in	Withdrawn
2312-0317-S	Height 17 mm	Withdrawn
2312-0215	Lordotic Angle 12 Deg	Withdrawn
2307-0211-N	Height 11 mm	Withdrawn
2312-1116	Lordotic Angle 12 Deg	Withdrawn
2312-1112-S	Lordotic Angle 12 Deg	Withdrawn
2307-0114-N	Height 14 mm	Withdrawn
2300-6525	Outer Diameter 6.5 mm	Withdrawn
2307-0210-S	Lordotic Angle 7 Deg	Withdrawn
2307-0317-N	Height 17 mm	Withdrawn
2312-0217-S	Lordotic Angle 12 Deg	Withdrawn
2900-1016	Height 5 in	Withdrawn
2312-1112	Depth 21 mm	Withdrawn
2307-0112-S	Height 12 mm	Withdrawn
2307-0116-N	Lordotic Angle 7 Deg	Withdrawn
2312-0211	Height 11 mm	Withdrawn
2307-0311-N	Height 11 mm	Withdrawn
2312-0315-N	Lordotic Angle 12 Deg	Withdrawn
2312-1111-S	Lordotic Angle 12 Deg	Withdrawn
2312-1111-N	Lordotic Angle 12 Deg	Withdrawn
2312-0216	Height 16 mm	Withdrawn
2307-0312-S	Height 12 mm	Withdrawn
2312-0114-S	Lordotic Angle 12 Deg	Withdrawn
2312-1112-N	Height 12 mm	Withdrawn
2307-0311	Lordotic Angle 7 Deg	Withdrawn
2112-9117	Height 17 mm	Withdrawn
2312-0313	Height 13 mm	Withdrawn
2312-0312	Lordotic Angle 12 Deg	Withdrawn
2312-7410	Lordotic Angle 12 Deg	Withdrawn
2307-0210-N	Height 10 mm	Withdrawn
2112-9312	Lordotic Angle 12 Deg	Withdrawn
2307-0315	Lordotic Angle 7 Deg	Withdrawn
2307-0217	Lordotic Angle 7 Deg	Withdrawn
2307-0112	Height 12 mm	Withdrawn
2112-9212	Lordotic Angle 12 Deg	Withdrawn
2301-0004	Length 10 in	Withdrawn
2312-1115-S	Lordotic Angle 12 Deg	Withdrawn
2307-0217-S	Lordotic Angle 7 Deg	Withdrawn
2307-0310-N	Height 10 mm	Withdrawn
2301-0006	Length 12 in	Withdrawn
2307-0114	Lordotic Angle 7 Deg	Withdrawn
2312-0312-S	Height 12 mm	Withdrawn
2112-9211	Height 11 mm	Withdrawn
2312-1115	Lordotic Angle 12 Deg	Withdrawn
2300-5530	Length 30 mm	Withdrawn
2307-0316-S	Height 16 mm	Withdrawn
2307-0110-N	Height 10 mm	Withdrawn
2307-0315-S	Height 15 mm	Withdrawn
2312-9417	Height 17 mm	Withdrawn
2300-1046	Length 6 in	Withdrawn
2300-1315		Withdrawn
2312-7412	Lordotic Angle 12 Deg	Withdrawn
2300-1038	Width 6 in	Withdrawn
2307-0216-S	Height 16 mm	Withdrawn
2312-7414	Height 14 mm	Withdrawn
2312-0112	Width 32 mm	Withdrawn
2112-9208	Height 8 mm	Withdrawn
2307-0213-S	Height 13 mm	Withdrawn
2312-9408	Height 8 mm	Withdrawn
2307-0216-N	Lordotic Angle 7 Deg	Withdrawn
2312-0316-S	Lordotic Angle 12 Deg	Withdrawn
2312-7414	Angle 12 °	Withdrawn
2112-9217	Height 17 mm	Withdrawn
2312-1114	Height 14 mm	Withdrawn
2307-0216	Height 16 mm	Withdrawn
2300-1101	Length 9.5 in	Withdrawn
2307-0117-N	Height 17 mm	Withdrawn
2307-0212-N	Height 12 mm	Withdrawn
2312-0111	Lordotic Angle 12 Deg	Withdrawn
2312-0310-S	Lordotic Angle 12 Deg	Withdrawn
2307-9010	Height 10 mm	Withdrawn
2312-0214	Lordotic Angle 12 Deg	Withdrawn
2312-0313-S	Lordotic Angle 12 Deg	Withdrawn
2312-0116-S	Height 16 mm	Withdrawn
2300-5525	Outer Diameter 5.5 mm	Withdrawn
2307-0110	Height 10 mm	Withdrawn
2312-0313-N	Lordotic Angle 12 Deg	Withdrawn
2307-0113-S	Lordotic Angle 7 Deg	Withdrawn
2112-9108	Height 8 mm	Withdrawn
2300-1100	Length 9.5 in	Withdrawn
2300-1035	Length 12 in	Withdrawn
2900-1001	Height 6 in	Withdrawn
2312-0314	Lordotic Angle 12 Deg	Withdrawn
2300-1313		Withdrawn
2307-0111-S	Lordotic Angle 7 Deg	Withdrawn
2312-0311-S	Lordotic Angle 12 Deg	Withdrawn
2312-0212-S	Lordotic Angle 12 Deg	Withdrawn
2312-0117	Height 17 mm	Withdrawn
2312-1114-N	Height 14 mm	Withdrawn
2312-0110-S	Height 10 mm	Withdrawn
2312-0113	Height 13 mm	Withdrawn
2900-1050	Width 10 in	Withdrawn
2307-9011	Height 11 mm	Withdrawn
2312-0214-N	Height 14 mm	Withdrawn
2307-0116-S	Height 16 mm	Withdrawn
2307-0111	Lordotic Angle 7 Deg	Withdrawn
2301-0007	Length 12 in	Withdrawn
2300-1302	Length 11 in	Withdrawn
2312-0217-N	Height 17 mm	Withdrawn
2307-0214-N	Lordotic Angle 7 Deg	Withdrawn
2307-0213	Height 13 mm	Withdrawn
2307-0215	Height 15 mm	Withdrawn
2312-0216-N	Height 16 mm	Withdrawn
2112-9315	Lordotic Angle 12 Deg	Withdrawn
2312-0110-N	Lordotic Angle 12 Deg	Withdrawn
2312-7412	width(MLxAP), 36 x 21, mm	Withdrawn
2312-0113-N	Lordotic Angle 12 Deg	Withdrawn
2312-0217	Lordotic Angle 12 Deg	Withdrawn
2307-0316-N	Lordotic Angle 7 Deg	Withdrawn
2112-9308	Height 8 mm	Withdrawn
2312-1110-S	Lordotic Angle 12 Deg	Withdrawn
2312-0110	Height 10 mm	Withdrawn
2112-9317	Lordotic Angle 12 Deg	Withdrawn
2312-0317-N	Height 17 mm	Withdrawn
2300-1120	Length 15 in	Withdrawn
2312-0310	Lordotic Angle 12 Deg	Withdrawn
2300-1015	Length 15 in	Withdrawn
2307-0314-S	Lordotic Angle 7 Deg	Withdrawn
2312-0212-N	Height 12 mm	Withdrawn
2312-9409	Height 9 mm	Withdrawn
2307-0214	Height 14 mm	Withdrawn
2307-9013	Height 13 mm	Withdrawn
2900-1001	Height 6 in	Withdrawn
2312-0215-N	Lordotic Angle 12 Deg	Withdrawn
2112-9210	Lordotic Angle 12 Deg	Withdrawn
2307-0317-S	Width 40 mm	Withdrawn
2307-0117	Lordotic Angle 7 Deg	Withdrawn
2312-1116-N	Height 16 mm	Withdrawn
2307-0210	Height 10 mm	Withdrawn
2312-0314-S	Height 14 mm	Withdrawn
2312-7410	width(MLxAP), 36 x 21, mm	Withdrawn
2312-0213	Lordotic Angle 12 Deg	Withdrawn
2312-0116	Height 16 mm	Withdrawn
2307-0211-S	Lordotic Angle 7 Deg	Withdrawn
2312-0213-S	Lordotic Angle 12 Deg	Withdrawn
2900-1006	Length 23 in	Withdrawn
2112-9109	Lordotic Angle 12 Deg	Withdrawn
2112-9216	Lordotic Angle 12 Deg	Withdrawn
2312-1110	width(MLxAP), 36 x 21, mm	Withdrawn
2112-9209	Height 9 mm	Withdrawn
2307-9014	Height 14 mm	Withdrawn
2312-0115-N	Lordotic Angle 12 Deg	Withdrawn
2312-0316-N	Lordotic Angle 12 Deg	Withdrawn
2307-0115-N	Height 15 mm	Withdrawn
2112-9114	Lordotic Angle 12 Deg	Withdrawn
2112-9115	Height 15 mm	Withdrawn
2312-7416	Height 16 mm	Withdrawn
2112-9112	Height 12 mm	Withdrawn
2307-0117-S	Lordotic Angle 7 Deg	Withdrawn
2312-0214-S	Height 14 mm	Withdrawn
2307-0214-S	Lordotic Angle 7 Deg	Withdrawn
2307-0315-N	Lordotic Angle 7 Deg	Withdrawn
2312-0115-S	Height 15 mm	Withdrawn
2307-0212-S	Height 12 mm	Withdrawn
2312-0310-N	Lordotic Angle 12 Deg	Withdrawn
2312-0117-N	Lordotic Angle 12 Deg	Withdrawn
2312-0210-S	Lordotic Angle 12 Deg	Withdrawn
2312-1111	Lordotic Angle 12 Deg	Withdrawn
2300-1100	Length 9.5 in	Withdrawn
2312-0212	Lordotic Angle 12 Deg	Withdrawn
2312-9411	Height 11 mm	Withdrawn
2307-0114-S	Lordotic Angle 7 Deg	Withdrawn
2312-1117	Height 17 mm	Withdrawn
2312-0210	Height 10 mm	Withdrawn
2307-0311-S	Lordotic Angle 7 Deg	Withdrawn
2312-1116-S	Height 16 mm	Withdrawn
2312-0111-N	Height 11 mm	Withdrawn
2312-1114-S	Lordotic Angle 12 Deg	Withdrawn
2312-1113	width(MLxAP), 36 x 21, mm	Withdrawn
2312-0317	Lordotic Angle 12 Deg	Withdrawn
2112-9214	Height 14 mm	Withdrawn
2312-0117-S	Angle 12 °	Withdrawn
2307-0310	Lordotic Angle 7 Deg	Withdrawn
2300-1036	Length 11 in	Withdrawn
2307-0313	Lordotic Angle 7 Deg	Withdrawn
2307-0314	Lordotic Angle 7 Deg	Withdrawn
2312-1115-N	Lordotic Angle 12 Deg	Withdrawn
2312-1117-S	Lordotic Angle 12 Deg	Withdrawn
2312-0114-N	Lordotic Angle 12 Deg	Withdrawn
2300-1034	Length 11 in	Withdrawn
2307-0215-N	Height 15 mm	Withdrawn
2312-1110	Height 10 mm	Withdrawn
2312-0213-N	Lordotic Angle 12 Deg	Withdrawn
2900-1051		Withdrawn
2112-9110	Lordotic Angle 12 Deg	Withdrawn
2300-6520	Outer Diameter 6.5 mm	Withdrawn
2300-1102	Length 12.5 in	Withdrawn
2307-0316	Lordotic Angle 7 Deg	Withdrawn
2112-9111	Lordotic Angle 12 Deg	Withdrawn
2307-0112-N	Height 12 mm	Withdrawn
2307-0310-S	Height 10 mm	Withdrawn
2300-1312		Withdrawn
2900-1052	Length 21 in	Withdrawn
2301-0003	Length 10 in	Withdrawn
2307-0312-N	Height 12 mm	Withdrawn
2312-0312-N	Lordotic Angle 12 Deg	Withdrawn
2112-9311	Height 11 mm	Withdrawn
2312-1113-S	Lordotic Angle 12 Deg	Withdrawn
2301-0005	Length 12 in	Withdrawn
2312-0210-N	Lordotic Angle 12 Deg	Withdrawn

Showing 250 of 271 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sirion	Astura Medical	1,465
IdentiTi	Alphatec Spine, Inc.	1,372
EL Capitan	Astura Medical	1,205
Zavation	Zavation	1,157
Brigade	Nuvasive, Inc.	1,005
Solar™ Interbody Fusion System	Degen Medical	899
Zavation F3D Corpectomy	Zavation	730
ROI-A	Ldr Spine USA	552
Avenue L	Ldr Spine USA	524
Transcend Nanotec	Alphatec Spine, Inc.	485
Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology	Titan Spine, LLC	462
Base	Nuvasive, Inc.	462

Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K191581	2020-01-08
K192054	2019-08-29
K163269	2017-04-13
K111626	2011-09-09

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Endoskeleton® TAS
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Medtronic Sofamor Danek USA, Inc.	510(k) number	2021-09-02	Class II	Packaging change control	Engraving on implants may not match what is listed on the pouch labels.	10 units	2023-10-05

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Endoskeleton® TAS