FDA.reportPublic FDA data

NA

Primary DI
10885862052162
Brand
NA
Company
Exactech, Inc.
Model
205-55-09
Catalog number
205-55-09
Device description
TIBIAL SPACER BLOCK SZ 1 & 3; 9MM
Published
2022-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862052162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586205216210885862052162

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
Device Size Text, specify0
Height0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862088130Equinoxe321-98-08321-98-082022-10-04
10885862086075NA315-98-43315-98-432022-09-20
10885862086082NA315-98-44315-98-442022-09-20
10885862086099NA315-98-45315-98-452022-09-20
10885862086105NA315-98-46315-98-462022-09-20
10885862086112NA315-98-47315-98-472022-09-20
10885862086129NA315-98-48315-98-482022-09-20
10885862086136NA315-98-49315-98-492022-09-20
10885862086143NA315-98-50315-98-502022-09-20
10885862086150NA315-98-51315-98-512022-09-20
10885862086167NA315-98-52315-98-522022-09-20
10885862086174NA315-98-53315-98-532022-09-20
10885862086181NA315-98-54315-98-542022-09-20
10885862253620GPS521-78-03521-78-032022-09-19
10885862052179NA205-55-11205-55-112022-08-25
10885862052186NA205-55-13205-55-132022-08-25
10885862052193NA205-55-15205-55-152022-08-25
10885862085733Equinoxe315-98-01315-98-012022-08-18
10885862085740Equinoxe315-98-02315-98-022022-08-18
10885862085757Equinoxe315-98-03315-98-032022-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606191715Overwatch PCFSPINAL ELEMENTS, INC.HWT2026-07-31
00840311211470Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWT2026-07-30
18257200103096ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103102ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103119ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103126ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103133ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103140ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103157ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103164ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103522ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103539ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103546ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103553ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103560ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103577ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103584ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103591ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103607ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103614ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103782ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103799ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103805ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103812ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103829ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103836ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103843ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103850ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103867ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103935ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17