FDA.reportPublic FDA data

OviTex®

Primary DI
00856072005654
Brand
OviTex®
Company
TELA BIO, INC.
Model
F10345-0610T
Device description
The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856072005654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856072005654008560720056548560720056540856072005654

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Centimeter
Width10Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-844-835-2246customerservice@telabio.com

Regulatory Flags#

DUNS number
078721472
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055071203OviTex® F10381-0305TF10381-0305T2026-03-27
00810055071173OviTex® F10379-1317TF10379-1317T2025-12-05
00810055071166OviTex® F10378-0715TF10378-0715T2025-08-06
00810055071159OviTex® F10377-1515T2025-07-08
00810055070183OviTex® PRSP20163-1620GP20163-1620G2023-07-12
00810055070275OviTex® PRSP20163-2020GP20163-2020G2023-07-12
00810055070442OviTex® PRSP20363-2025GP20363-2025G2023-07-12
00810055070619OviTex® PRSP20263-0815GP20263-0815G2023-07-12
00810055070770OviTex® PRSP20263-1020GP20263-1020G2023-07-12
00810055070855OviTex® PRSP20263-1122GP20263-1122G2023-07-12
00810055071067OviTex® PRSP20463-2525GP20463-2525G2025-02-21
00810055071074OviTex® PRSP20363-2530GP20363-2530G2025-02-21
00856072005050OviTex® PRSR20143-0820PR20143-0820P2025-02-21
00856072005142OviTex® PRSR20243-1122P2022-01-04
00856072005043OviTex® PRSR20143-0416P2020-09-14
00856072005074OviTex® PRSR20143-2020P2020-09-14
00856072005135OviTex® PRSR20243-1018P2020-09-14
00856072005005OviTex® PRSR20152-1620G2020-05-15
00856072005012OviTex® PRSR20152-2020G2020-05-15
00856072005029OviTex® PRSR20252-0815G2020-05-15

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Primary DI, Brand, Company table
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10886982351142VOLTSynthes GmbHFZX2026-09-25
10886982351692VOLTSynthes GmbHFZX2026-09-25
10886982357182VOLTSynthes GmbHFZX2026-09-25
00190776432164MillenniumAvalign Technologies, Inc.FZX2026-09-22
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00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
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00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
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