FDA.reportPublic FDA data

DELTA

Primary DI
37613327598255
Brand
DELTA
Company
Stryker Leibinger GmbH & Co. KG
Model
75-22126
Catalog number
75-22126
Device description
Delta screw 12 PK
Published
2025-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone
MAIFastener, fixation, biodegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993061000STRYKER LEIBINGER RESORBABLE FIXATION SYSTEMStryker Instruments1999-11-19MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327598255PrimaryGS10
07613327598254Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332759825537613327598255
07613327598254076133275982547613327598254

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, bioabsorbableA small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device may be self-drilling/self-tapping. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, and craniotomy flap fixation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature049 Degrees Celsius

Regulatory Flags#

DUNS number
316153956
Device count
12
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252578208NA78-2102878-210282015-07-03
07613252578215NA78-2002878-200282015-07-03
07613252578222NA78-2002078-200202015-07-03
07613252578239NA78-2102078-210202015-07-03
07613252599647NA78-3002078-300202015-07-03
07613252599654NA78-3002878-300282015-07-03
07613252599661NA78-3102078-310202015-07-03
07613252599678NA78-3102878-310282015-07-03
07613327392715DELTA70-7620170-762012018-06-07
04546540364883NA50-1290050-129002023-02-13
07613327369489AXS62-1217862-121782019-09-11
04546540246332NA60-1010460-101042016-08-24
04546540246356NA60-1010860-101082016-08-24
04546540246387NA60-1011260-101122016-08-24
04546540256805NA62-0053462-005342016-10-19
04546540258991NA62-1740162-174012016-10-19
04546540274175NA64-0010564-001052016-12-08
04546540274250NA64-0013264-001322017-01-11
04546540356758NA64-0024264-002422016-12-08
04546540356765NA64-0024364-002432016-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346003918Fine TTOLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
20653405990908GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990915GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990922GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990939GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990946GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990953GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30