FDA.reportPublic FDA data

Airlock®

Primary DI
03700879512655
Brand
Airlock®
Company
NOVASTEP
Model
XDG01023
Catalog number
XDG01023
Device description
Drill guide for screw Ø3.5
Published
2020-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143523000Airlock osteosynthesis plate systemNovastep2015-04-06HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700879512655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700879512655037008795126553700879512655

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33299338650contact@novastep-ortho.com
+33299338650regulatory-IntFA@enovis.com

Regulatory Flags#

DUNS number
264255288
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700879515687Airlock®XPP01006XPP010062026-08-25
03700879517803airlock®ACC1022P0002ACC1022P00022026-08-17
03700879515540airlock®XDB01027XDB010272026-07-10
03700879518701NAXMS01056XMS010562026-06-23
03700879518718NAXMS01057XMS010572026-06-23
03700879518725NAXMS01058-1XMS01058-12026-06-23
03700879518732NAXMS01058-2XMS01058-22026-06-23
03700879518565PECAPLASTY®ACC1025P0001ACC1025P00012026-03-19
03700879518572PECAPLASTY®ACC1025P0002ACC1025P00022026-03-19
03700879518589PECAPLASTY®XMS01055-1XMS01055-12026-03-19
03700879518596PECAPLASTY®XMS01055-2XMS01055-22026-03-19
03700879516479arcad® 2.0CSK101012CSK1010122024-08-08
03700879516486arcad® 2.0CSK121212CSK1212122024-04-16
03700879516493arcad® 2.0CSK151515CSK1515152024-04-16
03700879516509arcad® 2.0CSK181818CSK1818182024-04-16
03700879516516arcad® 2.0CSK202020CSK2020202024-04-16
03700879516523arcad® 2.0CSK252020CSK2520202024-04-16
03700879516530arcad® 2.0CSK261818CSK2618182024-04-16
03700879516547arcad® 2.0CSK302020CSK3020202024-04-16
03700879516554arcad® 2.0CSK301612CSK3016122024-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M9432002220000MinutemanSpinal Simplicity, LLCLXH2026-09-04
07613327697209PANGEAStryker GmbHLXH2026-08-27
10888857599710YUKON OCT Spinal SystemVB Spine LLCLXH2026-08-25
10888857613812K2M General InstrumentsVB Spine LLCLXH2026-06-12
10888857613805Xia® 3VB Spine LLCLXH2026-06-11
10888857596900OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596917OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596924OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596931OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596948OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
07640176970740Resection CheckerNaviswiss AGLXH2025-08-12
07640176970108Set of NAVItags (sterile, single-use)Naviswiss AGLXH2024-05-16
07640176970115Tag adapter PNaviswiss AGLXH2024-05-16
07640176970122Tag adapter M (magnetic)Naviswiss AGLXH2024-05-16
07640176970153Hex screwdriver SW3.5mm (AO coupling)Naviswiss AGLXH2024-05-16
07640176970177Tag adapter FNaviswiss AGLXH2024-05-16
07640176970191Pelvic caliperNaviswiss AGLXH2024-05-16
07640176970214Speed pin (3.0 x 80 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970221Speed pin adapterNaviswiss AGLXH2024-05-16
07640176970238Cortical bone screwNaviswiss AGLXH2024-05-16
07640176970252Calibration barNaviswiss AGLXH2024-05-16
07640176970320Tag adapter M (quick-lock)Naviswiss AGLXH2024-05-16
07640176970337PointerNaviswiss AGLXH2024-05-16
07640176970375Hex screwdriver SW3.5mm spherical headNaviswiss AGLXH2024-05-16
07640176970467Cortical bone screw (self drilling, 3.5 x 23 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970481Single-pin tag mount (self-drilling, wear part)Naviswiss AGLXH2024-05-16
07640176970498Single-pin tag mount AO adapterNaviswiss AGLXH2024-05-16
07640176970511Speed pin (3.0 x 110 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970542Acetabular Adapter PNaviswiss AGLXH2024-05-16
07640176970610Single-pin tag mount short (self drilling, wear part)Naviswiss AGLXH2024-05-16